Accessories, Catheter, G-U

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Jiangsu. All of them are contract manufacturers, able to build to a buyer’s own specification.

Conod Medical Shuyang Co., Ltd. Jiangsu, contract manufacturer

How Is KNY Classified?

Accessories, Catheter, G-U is FDA product code KNY, Class 2, 21 CFR 876.5130.

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. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Process control (1), Nonconforming Material/Component (1) and Storage (1).

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

Accessories, Catheter, G-U

RocaFlex Access Sheath & Dilation Catheter 12/14x45cm

Catalogue number AS121445, listed by Promepla, United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

Stone Center Silhouette

Kit Contains: B3827, SIL MUL-LGTH COMFORT 4.6Fx22-30CM B8134, UROWIRE 1/BX

Accessories, Catheter, G-U

RocaFlex Access Sheath & Dilation Catheter 10/12x45cm

Catalogue number AS121435, listed by Promepla, United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

Bard® Large Nylon Catheter Plug

Catalogue number 0414L, listed by C.R. Bard, Inc., United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

Acucise® Procedural Pack Universal Pack B

Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3302, STENT, C-FLEX, 7/10F X 28CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX

Accessories, Catheter, G-U

RocaFlex Access Sheath & Dilation Catheter 12/14x35cm

Catalogue number AS101245, listed by Promepla, United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

BI-Flex Access Sheath – 12 Inner / 14 Outer – Length 35cm

Catalogue number ROUS1235ST, listed by Promepla, United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

Halyard

MIC* Gastric-Jejunal Feeding Tube with ENFit® Connectors (Endoscopic/Radiologic Placement Kit)

Accessories, Catheter, G-U

Bard® Small Nylon Catheter Plug

Catalogue number 0414S, listed by C.R. Bard, Inc., United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

BI-Flex Access Sheath – 10 Inner / 12 Outer – Length 45cm

Catalogue number ROUS1045ST, listed by Promepla, United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

Accessories, Catheter, G-U

Insertion Mandrin

Accessories, Catheter, G-U

Acucise® Endopyelotomy System

Kit Includes: B1201, URO TAMPONADE BALLOON CATH H-110, HANDLE 10CC LF SEAL-005, SURESEAL II, INT. BOX/10, CE UROWIRE

Accessories, Catheter, G-U

Acucise® Procedural Pack Female Pack B

Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3301, STENT, C-FLEX, 7/10F X 26CM B7076, FORTE AxP SET 12/14/18F 28CM 6/BX

Accessories, Catheter, G-U

Acucise® Procedural Pack Universal Pack A

Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3301, STENT, C-FLEX, 7/10F X 26CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX

Accessories, Catheter, G-U

RocaFlex Access Sheath & Dilation Catheter 10/12x35cm

Catalogue number AS101235, listed by Promepla, United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

Vari-Pass

VARI-PASS 10/12 FR (3.3/4 mm) x 54 cm ADJUSTABLE LENGTH ACCESS SHEATH (5/PK)

Accessories, Catheter, G-U

Bard® Drainage Protector and Catheter Plug

Catalogue number 000076, listed by C.R. Bard, Inc., United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

Bi-Flex

BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 35cm

Accessories, Catheter, G-U

Silhouette® Pediatric Ureteral Stent With Urowire® Guidewire

Designed for patients 2 years and older for Temporary indwelling ureteral catheter to assist in urine drainage

Accessories, Catheter, G-U

UroWire® Guidewire With SL-6® Hydrophilic Coating

Urological Guidewire

Accessories, Catheter, G-U

Acucise® Procedural Pack Universal Pack C

Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX

Accessories, Catheter, G-U

Bard® “C” Clamp

Catalogue number 0458, listed by C.R. Bard, Inc., United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

Dover

Catheter Plug With CAP

Accessories, Catheter, G-U

Acucise® Procedural Pack Starter Pack

Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B1201, URO TAMPONADE BALLOON CATH B3304, STENT, C-FLEX 7/10F x 24 CM B3301, STENT, C-FLEX, 7/10F X 26CM B3302, STENT, C-FLEX, 7/10F X 28CM…

Accessories, Catheter, G-U

Ureteral Access Sheath With 2, 3 Fr Working Channels Dilator, 10frx45cm

4 catalogue numbers from 09-0017, listed by Promepla, United States, under Accessories, Catheter, G-U. 1 manufacturer in China is registered for this product code.

Accessories, Catheter, G-U

Acucise® Custom KIT

Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM

Accessories, Catheter, G-U

Gyrus Acmi, Inc

UroPass Ureteral Access Sheath 10/12 Fr (3.3/4 mm) x 38 cm (5/PK)

Accessories, Catheter, G-U

UroPass

UroPass Ureteral Access Sheath 11/13 Fr (3.7/4.3 mm) x 24 cm (5/PK)

Accessories, Catheter, G-U

BI-Flex Access Sheath – 12 Inner / 14 Outer – Length 45cm

Catalogue number ROUS1245ST, listed by Promepla, United States, under Accessories, Catheter, G-U. 1 manufacturer in China is 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