Otsc System Set
The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall…
The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant
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.
| 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
| Listed by | Ovesco Endoscopy AG, Germany |
|---|---|
| FDA product code | PKL |
| Device type | Hemostatic Metal Clip For The Gi Tract |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4400 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K101428 |
| Record published | 2015-09-18 |
| Record revised | 2021-04-07 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14/6 a | clip type “a” has blunt teeth | In distribution |
| 12/3 t – 220 | clip type “t” has pointed teeth | In distribution |
| 11/6 t | clip type “t” has pointed teeth | In distribution |
| 11/3 t | clip type “t” has pointed teeth | In distribution |
| 11/3 a | clip type “a” has blunt teeth | In distribution |
| 14/3 t | thread length 220 cm | In distribution |
| 12/6 gc | clip type “gc” has long, pointed teeth | In distribution |
| 12/3 t | clip type “t” has pointed teeth | In distribution |
| 14/6 t | thread length 220 cm | In distribution |
| 14/3 a | thread length 220 cm | In distribution |
| 11/6 a | thread length 165 cm | In distribution |
| 12/3 a | thread length 165 cm | In distribution |
| 12/3 a – 220 | clip type “a” has blunt teeth | In distribution |
| 12/6 a – 220 | clip type “a” has blunt teeth | In distribution |
| 12/6 t – 220 | thread length 220 cm | In distribution |
| 12/6 a | thread length 165 cm | In distribution |
| 12/6 t | thread length 165 cm | In distribution |
Same 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 USA | 17 |
| Single Use Multiclip Device | Micro-Tech (Nanjing) Co., Ltd. | 12 |
| Anrei | Anrei Medical(HZ) Co., Ltd. | 9 |
Showing 12 of 52. All products under Hemostatic Metal Clip For The Gi Tract
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251562 | 2025-12-18 |
| K241858 | 2024-08-26 |
| K200684 | 2020-06-02 |
| K183309 | 2019-10-22 |
| K170867 | 2017-07-25 |
| K153550 | 2016-10-12 |
| K150067 | 2015-09-16 |
| K101428 | 2010-12-01 |
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.