SureClip(®MINI) Repositionable Hemostasis Clip
SureClip MINI is a repositionable endoscopic hemostasis clip for adult gastrointestinal procedures through straight or side-viewing flexible endoscopes. The sterile, single-use device…
SureClip MINI is a repositionable endoscopic hemostasis clip for adult gastrointestinal procedures through straight or side-viewing flexible endoscopes. The sterile, single-use device combines a clip assembly and delivery system.
The family includes opening widths of 8, 11 and 16 mm and working lengths of 1,650 or 2,350 mm. An endoscope channel of at least 2.8 mm is required.
Listed Item
Open width8+2/0mm the max OD of insertion part 2.6mm working length 1650mm coated, 2 pcs in the box, single rotation wire
Clinical Uses
Uses include marking and bleeding control for mucosal defects under 3 cm, ulcers, polyps under 1.5 cm, colonic diverticula and arteries under 2 mm. It can provide prophylactic clipping after lesion resection and supplement conservative closure of luminal perforations under 20 mm.
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 9) |
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, box of 2, case of 25 |
| Sizes | Length 165 to 235 cm; outer diameter 2.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ROCC-C-26-235-C-R | Length 235 cm | In distribution |
| ROCC-C-26-235-C-N | Length 235 cm | In distribution |
| ROCC-C-26-165-C-N | Length 165 cm | In distribution |
| ROCC-C-26-165-C-R | Length 165 cm | In distribution |
| ROCC-C-26-235-C-R | Length 235 cm | In distribution |
| ROCC-C-26-165-C-R | Length 165 cm | In distribution |
| ROCC-C-26-165-C-N | Length 165 cm | In distribution |
| ROCC-C-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.