SureClip(®) Repositionable Hemostasis Clip
The SureClip Repositionable Hemostasis Clip places clips in the digestive tract through a flexible endoscope. It is intended for adults and can be used for endoscopic marking and control of…
The SureClip Repositionable Hemostasis Clip places clips in the digestive tract through a flexible endoscope. It is intended for adults and can be used for endoscopic marking and control of selected sources of bleeding. A delivery system carries the clip assembly to the treatment location.
Its bleeding indications include ulcers, mucosal or submucosal defects under 3 centimetres, polyps under 1.5 centimetres, colonic diverticula and arteries under 2 millimetres. It also supports preventive clipping after lesion removal and supplementary closure of perforations under 20 millimetres that can be treated conservatively.
Listed Item
Open width11±1mm the max OD of insertion part 2.6mm working length 2350mm coated, 2 pcs in the box, single rotation wire
Endoscope and Supply
The device is used through straight or side viewing flexible endoscopes with a working channel of at least 2.8 millimetres. The clip assembly and delivery system are supplied sterile for a single use.
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 | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | PKL |
| Device type | Hemostatic Metal Clip For The Gi Tract |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4400 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K182556 |
| Record published | 2016-04-21 |
| Record revised | 2025-12-01 (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 |
| Packaging | Box of 2, case of 25, case of 10, box of 10 |
| Sizes | Length 165 to 235 cm; outer diameter 2.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ROCC-D-26-235-C-R | Length 235 cm | In distribution |
| ROCC-D-26-165-C-R | Length 165 cm | In distribution |
| ROCC-D-26-235-C-N | Length 235 cm | In distribution |
| ROCC-D-26-235-C-R | Length 235 cm | In distribution |
| ROCC-D-26-165-C-N | Length 165 cm | In distribution |
| ROCC-D-26-165-C-R | Length 165 cm | In distribution |
| ROCC-D-26-165-C-N | Length 165 cm | In distribution |
| ROCC-D-26-235-C-N | Length 235 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 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250229 | 2025-09-08 |
| K220157 | 2022-06-13 |
| K212748 | 2022-01-20 |
| K202333 | 2021-01-14 |
| K182556 | 2018-12-14 |
| K180325 | 2018-06-01 |
| K161463 | 2017-01-06 |
| K152001 | 2015-12-10 |
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.