Single Use Hemoclip
Single Use Hemoclip from Zhejiang Chuangxiang places clips endoscopically within the gastrointestinal tract in patients aged 18 and older. It consists of a delivery system and clip assembly…
Single Use Hemoclip from Zhejiang Chuangxiang places clips endoscopically within the gastrointestinal tract in patients aged 18 and older. It consists of a delivery system and clip assembly and is supplied sterile for one use.
Uses include endoscopic marking and hemostasis for mucosal or submucosal defects under 3 cm, bleeding ulcers, polyps under 1.5 cm and colonic diverticula. It can also supplement conservative treatment of luminal perforations under 20 mm.
Dimensions
Clip openings range from 9 to 16 mm across the available models. Working lengths are 1,650, 1,950, 2,300 and 2,700 mm. The device requires an endoscope working channel of at least 2.8 mm.
17manufacturers in China registered for this device type
80catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Zhejiang Chuangxiang Medical Technology 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, Repacker / relabeller, Manufacturer |
| 510(k) | K212669 |
| Record published | 2022-08-17 |
| Record revised | 2022-08-17 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10, case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MD-S-HR-165-9-090-N | In distribution | |
| MD-A-HR-270-16-090-N | In distribution | |
| MD-A-HR-195-16-090-N | In distribution | |
| MD-C-HR-195-13-135-N | In distribution | |
| MD-A-HR-230-16-135-N | In distribution | |
| MD-S-HR-165-9-090-Y | In distribution | |
| MD-A-HR-165-16-135-N | In distribution | |
| MD-C-HR-230-13-090-N | In distribution | |
| MD-A-HR-270-16-135-Y | In distribution | |
| MD-C-HR-165-13-090-Y | In distribution | |
| MD-S-HR-230-9-135-N | In distribution | |
| MD-G-HR-230-12-090-N | In distribution | |
| MD-C-HR-270-13-090-Y | In distribution | |
| MD-C-HR-195-13-090-Y | In distribution | |
| MD-A-HR-165-16-090-N | In distribution | |
| MD-S-HR-230-9-090-N | In distribution | |
| MD-G-HR-195-12-135-Y | In distribution | |
| MD-G-HR-195-12-135-N | In distribution | |
| MD-S-HR-270-9-135-N | In distribution | |
| MD-C-HR-270-13-135-Y | In distribution | |
| MD-C-HR-195-13-090-N | In distribution | |
| MD-L-HR-165-15-090-Y | In distribution | |
| MD-A-HR-230-16-090-Y | In distribution | |
| MD-C-HR-270-13-135-N | In distribution | |
| MD-G-HR-195-12-090-N | In distribution | |
| MD-S-HR-270-9-135-Y | In distribution | |
| MD-G-HR-165-12-090-Y | In distribution | |
| MD-L-HR-195-15-135-Y | In distribution | |
| MD-A-HR-270-16-090-Y | In distribution | |
| MD-L-HR-195-15-090-Y | In distribution | |
| MD-S-HR-195-9-090-N | In distribution | |
| MD-L-HR-165-15-090-N | In distribution | |
| MD-A-HR-230-16-135-Y | In distribution | |
| MD-C-HR-230-13-135-N | In distribution | |
| MD-G-HR-230-12-135-Y | In distribution | |
| MD-G-HR-270-12-090-N | In distribution | |
| MD-L-HR-270-15-090-N | In distribution | |
| MD-G-HR-195-12-090-Y | In distribution | |
| MD-S-HR-165-9-135-N | In distribution | |
| MD-L-HR-230-15-135-N | In distribution | |
| MD-A-HR-195-16-090-Y | In distribution | |
| MD-L-HR-270-15-090-Y | In distribution | |
| MD-L-HR-195-15-135-N | In distribution | |
| MD-A-HR-270-16-135-N | In distribution | |
| MD-S-HR-230-9-090-Y | In distribution | |
| MD-C-HR-270-13-090-N | In distribution | |
| MD-A-HR-195-16-135-Y | In distribution | |
| MD-L-HR-230-15-090-N | In distribution | |
| MD-G-HR-270-12-135-Y | In distribution | |
| MD-G-HR-165-12-090-N | In distribution | |
| MD-G-HR-230-12-090-Y | In distribution | |
| MD-G-HR-230-12-135-N | In distribution | |
| MD-S-HR-230-9-135-Y | In distribution | |
| MD-G-HR-165-12-135-Y | In distribution | |
| MD-L-HR-195-15-090-N | In distribution | |
| MD-L-HR-230-15-090-Y | In distribution | |
| MD-C-HR-230-13-135-Y | In distribution | |
| MD-L-HR-165-15-135-Y | In distribution | |
| MD-A-HR-195-16-135-N | In distribution | |
| MD-L-HR-230-15-135-Y | In distribution | |
| MD-S-HR-195-9-135-Y | In distribution | |
| MD-S-HR-270-9-090-N | In distribution | |
| MD-C-HR-165-13-135-Y | In distribution | |
| MD-L-HR-270-15-135-N | In distribution | |
| MD-G-HR-270-12-090-Y | In distribution | |
| MD-C-HR-165-13-135-N | In distribution | |
| MD-A-HR-165-16-090-Y | In distribution | |
| MD-S-HR-195-9-135-N | In distribution | |
| MD-S-HR-270-9-090-Y | In distribution | |
| MD-A-HR-230-16-090-N | In distribution | |
| MD-C-HR-165-13-090-N | In distribution | |
| MD-L-HR-270-15-135-Y | In distribution | |
| MD-A-HR-165-16-135-Y | In distribution | |
| MD-S-HR-195-9-090-Y | In distribution | |
| MD-C-HR-195-13-135-Y | In distribution | |
| MD-S-HR-165-9-135-Y | In distribution | |
| MD-C-HR-230-13-090-Y | In distribution | |
| MD-G-HR-165-12-135-N | In distribution | |
| MD-L-HR-165-15-135-N | In distribution | |
| MD-G-HR-270-12-135-N | 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 |
| 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 |
| 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 |
|---|---|
| K212669 | 2022-05-27 |
| K172762 | 2018-03-20 |
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.