Stent, Ureteral

Who Makes This Device Type in China?

4 manufacturers in China hold an FDA registration for this device type, concentrated in Shanghai, Guangdong and Zhejiang.

Alton Shanghai Medical Instruments Co Ltd Shanghai
BQ Plus Medical Co., Ltd. Shanghai, contract manufacturer
Shenzhen Trious Medical Technology Co., Ltd. Guangdong
Zhejiang Chuangxiang Medical Technology Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code FAD?

Stent, Ureteral is FDA product code FAD, Class 2, 21 CFR 876.4620.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 4 clearances under this code; the FDA took a median of 232 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 55 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Process control (30), Mixed-up of materials/components (6) and Labeling Change Control (4).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Stent, Ureteral

Percuflex™ Plus

300 catalogue numbers from M006175275110, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Porges Coloplast

VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 22 cm with non steerable pusher CH FR 4.8 and Orchestra™ guidewire and Flush ureteric catheter CH FR 06

Stent, Ureteral

Polaris™ Ultra

406 catalogue numbers from M006192122170, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Mardis Soft

20 catalogue numbers from M0061265730, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Percuflex™ Plus SureDrive™

19 catalogue numbers from M0061458540, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Bard® Fluoro-4™ Silicone Ureteral Coil Stent

Bard® Fluoro-4™ Silicone Ureteral Coil Stent with Hydro-Glide™ Guidewire

Stent, Ureteral

Applied Standard Ureteral Stent With SL-6® Hydrophilic Coating and Tether

Temporary indwelling ureteral catheter to assist in urine draining.

Stent, Ureteral

Tecoflex

7.0 FR (2.3mm) X 22 cm LUBRI-FLEX OPEN TIP URETERAL STENT HYDROPHILIC COATED TECOFLEX

Stent, Ureteral

R+

R+ Urinary Diversion Stents [Mono - J] Open Tip 4.7F, 70cm with Guidewire

Stent, Ureteral

Contour™

205 catalogue numbers from M006180221120, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Ascerta™

14 catalogue numbers from M0061456090, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Contour™ Injection Stent

Injection Stent

Stent, Ureteral

Polaris™ Loop

232 catalogue numbers from M006155220090, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Universa

Universa Firm Ureteral Stent and Positioner With Hydrophilic Coating and Monofilament Tether

Stent, Ureteral

Percuflex™

Ureteral Stent System with Dissolving Tip

Stent, Ureteral

Greene

Greene Renal Transplant Stent Set Wire Guide With Hydrophilic Coating

Stent, Ureteral

ImaJin

ImaJin ImaJin™. iso. Double loop ureteral stent kit. without eye on the straight section. Length 28 cm, Catheter Gauge 8 FR/CH.

Stent, Ureteral

Bard® InLay® Ureteral Stent With HydroGlide™ Guidewire

Inlay Ureteral Stent W/Hydroglide Guidewire

Stent, Ureteral

Biosoft

33 catalogue numbers from BCAA77, listed by Coloplast A/S, Denmark, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Bard® InLay® Ureteral Stent

INLAY URETERAL STENT w/o GUIDEWIRE

Stent, Ureteral

Tria™ Firm

Ureteral Stent Braided Suture w/o Side Holes 4.8Fx30CM

Stent, Ureteral

Silhouette® Scaffold Ureteral Stent

Temporary indwelling ureteral catheter to assist in urine drainage

Stent, Ureteral

Amplatz

Amplatz Ureteral Stent Set Ultrathane

Stent, Ureteral

Bardex® Soft Double Pigtail Ureteral Stent With Suture

Bardex Suture Stent W/ Hydroglide

Stent, Ureteral

Silhouette® Comfort Ureteral Stent

11 catalogue numbers from B3837, listed by Applied Medical Resources Corp., United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

RocaJJ Soft Stent – Ø 7 Fr – Length 28cm

2 catalogue numbers from ROJG9728ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

JFil® Ureteral Suture Stent

Comfort Stent 7Fr - 160 mm

Stent, Ureteral

Bard® InLay® Versa Fit® Ureteral Stent

INLAY VERSA FIT URETERAL STENT w/o GUIDEWIRE

Stent, Ureteral

ReSolve ConvertX®

37 catalogue numbers from 00884450452851, listed by Merit Medical Systems, Inc., United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Bard® InLay Optima® Ureteral Stent With HydroGlide™ Guidewire

Inlay Optima Ureteral Stent W/Hydroglide Guidewire

Stent, Ureteral

Vortek

Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stiff.

Stent, Ureteral

Flexima™

Ureteral Stent System Kit

Stent, Ureteral

ConvertX™ Nephroureteral Stent System

16 catalogue numbers from 10.3F x 20cm, listed by Brightwater Medical, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Tria™ Soft

30 catalogue numbers from M0061903240, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Bard® Fluoro-4™ Silicone Ureteral Stent

Bard® Fluoro-4™ Silicone Ureteral Stent with Hydro-Glide™ Guidewire

Stent, Ureteral

Sof-Flex

Sof-Flex is a ureteral stent family that provides temporary internal urinary drainage from the kidney's ureteropelvic junction to the bladder. A single internal lumen maintains a drainage…

Stent, Ureteral

SOF-Curl

SOF-CURL Ureteral Stent 6.0 FR X 24 cm w/PTFE Coated Extra Firm Guidewire 3 cm Flexible Tip .038" X 150 cm

Stent, Ureteral

Bard® InLay Optima® Ureteral Stent

Inlay Optima Ureteral Stent W/O Guidewire

Stent, Ureteral

Expel™ Ureteral Stent System

Ureteral Stent System

Stent, Ureteral

Endopyelotomy Stent With SL-6® Hydrophilic Coating

Temporary indwelling ureteral catheter to assist in urine draining.

Stent, Ureteral

Multi-Flex

MULTI-FLEX Open Tip Ureteral Stent 7.0 FR X 28 cm w/PTFE Moveable Core Guidewire .038" X 150 cm w/5 FR Open-End Ureteral Catheter

Stent, Ureteral

NovoFlow

Length 30 cm, Catheter Gauge 7 FR/CH.

Stent, Ureteral

Lithostent

LITHOSTENT Ureteral Stent 7.0 FR X 20 cm w/E-Z Glider Straight Tip Guidewire .038” X 150 cm

Stent, Ureteral

Resonance

Resonance, Metallic Ureteral Stent and Introducer

Stent, Ureteral

Q Urological Persistent Aguamedicina

The PERSISTENT AguaMedicina ureteral stent temporarily supports urine drainage from the kidney to the bladder. It is a tube-like implanted device used to maintain a drainage passage through…

Stent, Ureteral

Ultrathane

Ultrathane Endoureterotomy Stent Set

Stent, Ureteral

Expel™ Nephroureteral Stent System With Twist-Loc™ Hub

Nephroureteral Stent System

Stent, Ureteral

Black Silicone

Black Silicone Filiform Double Pigtail Ureteral Stent Set Wire Guide With Hydrophilic Coating

Stent, Ureteral

Bard® InLay Optima® Multilength Ureteral Stent With NiCore™ Guidewire

Inlay Optima Multi-Length Ureteral Stent W/Hydroglide Guidewire

Stent, Ureteral

All Soft Ureteral Stent – 6f, 26cm

6F, 26cm

Stent, Ureteral

URO-Guide

URO-GUIDE URETERAL STENT 8.5 FR (2.81 mm) X 16 cm

Stent, Ureteral

RocaJJ Soft Stent – Ø 4,8 Fr – Length 28cm

2 catalogue numbers from ROJS9528ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Contour VL™

Variable Length Ureteral Stent with HydroplusTM Coating

Stent, Ureteral

Cook

Black Silicone Filiform Double Pigtail Ureteral Stent Set

Stent, Ureteral

Percuflex™ Nephroureteral Stent

Nephroureteral Stent System with Dissolving Tip

Stent, Ureteral

Totalis™ Flexible Endo Kit

Totalis Flexible Endo Kit with InLay Optima® Ureteral Stent, SkyLite™ Tipless Stone Basket and Solo™ Plus Hybrid Guidewire

Stent, Ureteral

Stretch™ VL

Variable Length Flexima™ Stent with HydroplusTM Coating

Stent, Ureteral

C-Flex

C-Flex Double Pigtail Ureteral Stent Set

Stent, Ureteral

Cope

Cope Nephroureterostomy Stent Ultrathane

Stent, Ureteral

Uropass

UROPASS Open Tin Ureteral Stent 7.0 FR X 28 cm w/E-Z GLIDER Angle Tip Guidewire

Stent, Ureteral

RocaJJ Soft Stent – Ø 7 Fr – Length 24cm

2 catalogue numbers from ROJG9724ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

All Soft Ureteral Stent – 7f, 24cm With Suture

7F, 24cm with Suture

Stent, Ureteral

Bard® InLay® Ureteral Stent With NiCore™ Guidewire

Inlay Ureteral Stent W/Nitinol Guidewire

Stent, Ureteral

Kwart

Kwart Retro-Inject Ureteral Stent Set With AQ Hydrophilic Coating

Stent, Ureteral

LumaFlex Plus Double J Stent, 2 Open Tips, Ch/Fr6/L.26cm, Without Wire

4 catalogue numbers from 09-0178, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Double-J

8.5FR(2.81mm) X 30 cm SURGITEK DOUBLE-J CLOSED TIP URETERAL STENT

Stent, Ureteral

LumaFlex Double J Stent, 2 Open Tips, Ch/Fr7/L.26cm, Without Wire

Catalogue number 09-0134, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Bard® InLay Optima® Multilength Ureteral Stent

Inlay Optima Multilength Ureteral Stent W/O Guidewire

Stent, Ureteral

Allsoft

allSoft Urinary Diversion Stents [Mono - J] Open Tip 6F, 70cm with Guidewire

Stent, Ureteral

Uropass II

UROPASS II Open Tip Ureteral Stent 6.0 FR X 26 cm w/PTFE Movable Core Guidewire .038" X 150 cm w/5 FR Open-End Ureteral Catheter

Stent, Ureteral

Gyrus Acmi

CLASSIC Open Tip Ureteral Stent 8.5 FR X 22 cm w/PTFE Coated Moveable Core Guidewire .038” X 150 cm

Stent, Ureteral

Dornier MedTech

Cascade Ureteral Stent, 4.9Fr x 22-32cm Variable

Stent, Ureteral

Contour™ Injection Stent Set

Injection Stent Set

Stent, Ureteral

Bard® InLay Optima® Ureteral Stent With NiCore™ Guidewire

Inlay Optima Ureteral Stent W/Nitinol Guidewire

Stent, Ureteral

RocaJJ Soft Stent – Ø 4,8 Fr – Length 24cm

2 catalogue numbers from ROJS9524ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Trious

3 catalogue numbers from 231A5DG, listed by Shenzhen Trious Medical Technology Co., Ltd., China, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

RocaJJ Soft Stent – Ø 6 Fr – Length 30cm

2 catalogue numbers from ROJG9630ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Ascerta™ VL

3 catalogue numbers from M0061456290, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Surgitek

7.0FR (2.3mm) X 16 cm SURGITEK DOUBLE-J CLOSED TIP URETERAL STENT

Stent, Ureteral

LumaFlex Plus Double J Stent, 2 Open Tips, Ch/Fr7/L.26cm, Without Wire

4 catalogue numbers from 09-0183, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

RocaJJ Soft Stent – Ø 8 Fr – Length 26cm

2 catalogue numbers from ROJG9826ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

RocaJJ Soft Stent – Ø 8 Fr – Length 24cm

2 catalogue numbers from ROJG9824ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Contour™ SureDrive™

14 catalogue numbers from M0061458640, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

LumaFlex Double J Stent, 2 Open Tips, Ch/Fr4,8/L.26cm, Without Wire

4 catalogue numbers from 09-0126, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

RocaJJ Soft Stent – Ø 8 Fr – Length 28cm

2 catalogue numbers from ROJS9828ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Y-Clic Adapter

Catalogue number 09-0197, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Contour VL™ Injection Stent Set

Variable Length Injection Stent Set

Stent, Ureteral

Bard® InLay® Versa Fit® Ureteral Stent With NiCore™ Guidewire

Inlay Versa FIT Ureteral Stent W/Nitinol Guidewire

Stent, Ureteral

Q Urological Fuselage Aguamedicina

8 catalogue numbers from NP378SS0726, listed by Q Urological Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

RocaJJ Soft Stent – Ø 7 Fr – Length 26cm

2 catalogue numbers from ROJS9726ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

LumaFlex Double J Stent, 2 Open Tips, Ch/Fr7/L.30cm, Without Wire

Catalogue number 09-0136, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

RocaJJ Soft Stent – Ø 8 Fr – Length 30cm

2 catalogue numbers from ROJS9830ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Totalis™ Rigid Endo Kit

Totalis™ Rigid Endo Kit with InLay® VersaFit™ Ureteral Stent, EcoFlex™ Stone Basket and NiCore® Nitinol Guidewire

Stent, Ureteral

RocaJJ Soft Stent – Ø 6 Fr – Length 28cm

2 catalogue numbers from ROJS9628ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Bard® InLay® Versa Fit® Ureteral Stent With HydroGlide™ Guidewire

Inlay Versa FIT Ureteral Stent W/Hydroglide Guidewire

Stent, Ureteral

All Soft Ureteral Stent – 6f, 24cm With Suture

Ureteral Stent - 6F, 24cm with Suture

Stent, Ureteral

LumaFlex Double J Stent, 2 Open Tips, Ch/Fr6/L.28cm, Without Wire

Catalogue number 09-0131, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Silhouette® Xtraflo Ureteral Stent

11 catalogue numbers from B3858, listed by Applied Medical Resources Corp., United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Retromax™ Plus

Endopyelotomy Stent

Stent, Ureteral

LumaFlex Double J Stent, 2 Open Tips, Ch/Fr7/L.28cm, Without Wire

Catalogue number 09-0135, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

RocaJJ Soft Stent – Ø 4,8 Fr – Length 26cm

2 catalogue numbers from ROJS9526ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

All Soft Ureteral Stent – 6f, 26cm With Suture

Catalogue number 6F, 26cm with Suture, listed by Allwin Medical Devices, Inc., United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

LumaFlex Double J Stent, 2 Open Tips, Ch/Fr8/L.30cm, Without Wire

Catalogue number 09-0140, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

LumaFlex Double J Stent, 2 Open Tips, Ch/Fr6/L.26cm, Without Wire

Catalogue number 09-0130, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

RocaJJ Soft Stent – Ø 4,8 Fr – Length 30cm

2 catalogue numbers from ROJS9530ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Single J

8.5 FR(2.81mm) X 90 cm SINGLE J URINARY DIVERSION URETERAL STENT

Stent, Ureteral

Salle

Salle Intraoperative Pyeloplasty Stent Set With 3cm Stylet

Stent, Ureteral

Contour VL™ SureDrive™

3 catalogue numbers from M0061458740, listed by Boston Scientific Corporation, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Silhouette® Xtraflo Multi-Length Ureteral Stent

Catalogue number B3847, listed by Applied Medical Resources Corp., United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

All Soft Ureteral Stent – 6f, 24cm

Ureteral Stent - 6F, 24cm

Stent, Ureteral

Contour VL™ Injection Stent

Variable Length Injection Stent with HydroplusTM Coating

Stent, Ureteral

LumaFlex Double J Stent, 2 Open Tips, Ch/Fr6/L.30cm, Without Wire

Catalogue number 09-0132, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

RocaJJ Soft Stent – Ø 6 Fr – Length 26cm

2 catalogue numbers from ROJG9626ST, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Bard® Silicone Uretero-Intestinal Anastomosis Urinary Diversion Stent

Bard® Silicone Uretero-Intestinal Anastomosis Urinary Diversion Stent with Hydro-Glide™ Guidewire

Stent, Ureteral

Lubri-Flex

7.0FR(2.3mm)X 30 cm LUBRI-FLEX OPEN TIP URETERAL STENT HYDROPHILIC COATED TECOFLEX

Stent, Ureteral

All Soft Ureteral Stent – 7f, 26cm With Suture

Catalogue number 7F, 26cm with Suture, listed by Allwin Medical Devices, Inc., United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

Acucise® Procedural Pack

Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX B3305, STENT, C-FLEX 7/10F x 22 CM

Stent, Ureteral

LumaFlex Double J Stent, 2 Open Tips, Ch/Fr7/L.24cm, Without Wire

Catalogue number 09-0133, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Stent, Ureteral

All Soft Ureteral Stent – 7f, 22cm With Suture

7F, 22cm with Suture

Stent, Ureteral

LumaFlex Double J Stent, 2 Open Tips, Ch/Fr6/L.24cm, Without Wire

Catalogue number 09-0129, listed by Promepla, United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer