Who else makes this device?

Name: All Soft Ureteral Stent - 6F, 24cm
Brand: All Soft Ureteral Stent - 6F, 24cm

All Soft Ureteral Stent - 6f, 24cm · Stent, Ureteral → Gastroenterology & Urology

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (2), Zhejiang (1), Guangdong (1).

Chinese manufacturers registered for FDA product code FAD
Manufacturer	City	Province	Registered as	Device types
Zhejiang Chuangxiang Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Alton Shanghai Medical Instruments Co Ltd	Shanghai	Shanghai	Complaint-file establishment	20
BQ Plus Medical Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	13
Shenzhen Trious Medical Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	6

Record

Regulatory record for All Soft Ureteral Stent – 6F, 24cm
Listed by	Allwin Medical Devices, Inc., United States
FDA product code	FAD
Device type	Stent, Ureteral
Device class	Class 2
Regulation	21 CFR 876.4620
Establishment	Repacker / relabeller, Manufacturer, Exporter
510(k)	K190659
Record published	2020-09-21

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 10

Catalogue Numbers

Catalogue numbers for All Soft Ureteral Stent – 6F, 24cm
Catalogue number	Size	Status
Ureteral Stent – 6F, 24cm		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Porges Coloplast	Coloplast A/S	509
Polaris™ Ultra	Boston Scientific Corporation	406
Universa	Cook Incorporated	384
Percuflex™ Plus	Boston Scientific Corporation	300
Polaris™ Loop	Boston Scientific Corporation	232
ImaJin	Coloplast A/S	219
Contour™	Boston Scientific Corporation	205
Percuflex™	Boston Scientific Corporation	152
Tecoflex	Gyrus Acmi, Inc.	92
Vortek	Coloplast A/S	92
Sof-Flex	Cook Incorporated	60
Tria™ Firm	Boston Scientific Corporation	58

Showing 12 of 131. All products under Stent, Ureteral

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K190659	2019-12-02

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

All Soft Ureteral Stent – 6f, 24cm