Single Use Multiclip Device
Single Use MultiClip Device places endoscopic clips in the gastrointestinal tract for marking, hemostasis and selected supplementary closure procedures. It combines a delivery system with a…
Single Use MultiClip Device places endoscopic clips in the gastrointestinal tract for marking, hemostasis and selected supplementary closure procedures. It combines a delivery system with a clip assembly carrying three or five clips for sequential release. The device is supplied sterile for single use.
Hemostasis indications include mucosal or submucosal defects under 3 cm, bleeding ulcers, polyps under 1.5 cm and colonic diverticula. Supplementary closure is limited to luminal perforations under 20 mm that can be treated conservatively. These limits define the intended defect sizes.
Listed Item
5 clips in spring tube,the max OD of insertion part 2.6mm,working length 2350mm,coated
Endoscope Compatibility and Supply
The device requires a working channel of at least 2.8 mm and has a 10 mm clip-opening width. Working lengths include 1,250, 1,650, 1,950 and 2,350 mm. It is packaged in an ethylene-oxide-sterilized rigid tray with a sealable cover and a two-year shelf life.
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) | K180325 |
| Record published | 2023-06-28 |
| Record revised | 2025-12-19 (version 4) |
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, case of 10 |
| Sizes | Length 1650 to 2350 mm; outer diameter 2.6 to 3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MC-5-26-235 | Length 2350 mm | In distribution |
| MC-5-30-165 | Length 1650 mm | In distribution |
| MC-5-26-165 | Length 1650 mm | In distribution |
| MC-3-26-235 | Length 2350 mm | In distribution |
| MC-5-26-195 | Length 1950 mm | In distribution |
| MC-3-26-165 | Length 1650 mm | In distribution |
| MC-3-26-195 | Length 1950 mm | In distribution |
| MC-5-30-195 | Length 1950 mm | In distribution |
| MC-3-30-165 | Length 1650 mm | In distribution |
| MC-3-30-235 | Length 2350 mm | In distribution |
| MC-3-30-195 | Length 1950 mm | In distribution |
| MC-5-30-235 | Length 2350 mm | 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 |
| 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 |
|---|---|
| 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.