Assurance

The Assurance Control Clip - 11 mm is compatible with endoscopes and is indicated for clip placement within the digestive tract for the purpose of mechanical pressure treatment of bleeding…

Registry build 21.09.26

The Assurance Control Clip – 11 mm is compatible with endoscopes and is indicated for clip placement within the digestive tract for the purpose of mechanical pressure treatment of bleeding of small arteries and pulsation.

17manufacturers in China registered for this device type
9catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (9), Jiangsu (4), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PKL
Manufacturer City Province Registered as Device types
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Zhejiang Huanyi Sterilization Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 25
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Jiana Sterilization Technology (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 23
Promisemed Hangzhou Meditech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 21
Jiangsu Vedkang Medical Science and Technology Co., Ltd. Changzhou Jiangsu Manufacturer 20
Alton Shanghai Medical Instruments Co Ltd Shanghai Shanghai Complaint-file establishment 20
Hangzhou AGS MedTech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 19
Ningbo Huakun Medical Equipment Co., Ltd. Cixi Zhejiang Contract manufacturer 19
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13

Showing 12 of 17. All 17 manufacturers in China registered for Hemostatic Metal Clip For The Gi Tract

Record

Regulatory record for Assurance
Listed by Us Endoscopy, United States
FDA product code PKL
Device type Hemostatic Metal Clip For The Gi Tract
Device class Class 2
Regulation 21 CFR 876.4400
510(k) K172727
Record published 2021-07-22

Specifications

Specifications
MRI safety MR Conditional
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 10, box of 10
Sizes Outer diameter 2.6 mm

Catalogue Numbers

Catalogue numbers for Assurance
Catalogue number Size Status
00711883 In distribution
00711887 Outer Diameter 2.6 mm In distribution
00711885 Outer Diameter 2.6 mm In distribution
00711926 In distribution
00711882 In distribution
00711881 In distribution
00711884 In distribution
00711888 Outer Diameter 2.6 mm In distribution
00711927 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hemostatic Metal Clip For The Gi Tract Hangzhou AGS MedTech Co., Ltd. 368
Disposable Hemostatic Clips Ningbo Xinwell Medical Technology Co., Ltd. 160
Single Use Hemoclip Zhejiang Chuangxiang Medical Technology Co., Ltd. 80
SureClip Micro-Tech (Nanjing) Co., Ltd. 38
Lockado(TM) Repositionable Hemostasis Clip Micro-Tech (Nanjing) Co., Ltd. 32
Zksk Beijing Zksk Technology Co., Ltd. 30
RiteClip(TM) Repositionable Hemostasis Clip Micro-Tech (Nanjing) Co., Ltd. 30
S.t.a.r(TM) Disposable Hemostatic Closure Clip Device Micro-Tech (Nanjing) Co., Ltd. 24
Dual Action Tissue Closure Device Micro-Tech (Nanjing) Co., Ltd. 18
Otsc System Set Ovesco Endoscopy AG 17
Otsc System Set Ovesco Endoscopy USA 17
Single Use Multiclip Device Micro-Tech (Nanjing) Co., Ltd. 12

Showing 12 of 52. All products under Hemostatic Metal Clip For The Gi Tract

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.

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