Disposable Hemostatic Clips
Disposable Hemostatic Clips from Ningbo Xinwell place stainless steel clips within the gastrointestinal tract through a straight or side-viewing flexible endoscope. They are intended for…
Disposable Hemostatic Clips from Ningbo Xinwell place stainless steel clips within the gastrointestinal tract through a straight or side-viewing flexible endoscope. They are intended for adult patients and combine a clip section with a delivery assembly.
Before deployment, the clip can be opened and closed more than five times to reposition it. Single-ring and three-ring handle models include rotatable and nonrotatable versions. Each device is supplied sterile for single use.
Uses and Size Limits
Uses include marking, hemostasis, prophylactic clipping after lesion resection and anchoring jejunal feeding tubes. Specified bleeding targets include mucosal defects under 3 cm, polyps under 1.5 cm and arteries under 2 mm. Clips can supplement conservative treatment of luminal perforations under 20 mm.
17manufacturers in China registered for this device type
160catalogue numbers in this listing
1510(k) clearance
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 | Ningbo Xinwell 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, Manufacturer |
| 510(k) | K232969 |
| Record published | 2024-11-29 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| 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 10, case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XY-ZZJ-1A-2.5-2700-135-16 | In distribution | |
| XY-ZZJ-1A-2.5-2350-135-16 | In distribution | |
| XY-ZZJ-0B-2.5-2700-135-9 | In distribution | |
| XY-ZZJ-0B-2.5-2350-135-16 | In distribution | |
| XY-ZZJ-0B-2.5-1250-90-9 | In distribution | |
| XY-ZZJ-0B-2.5-1950-135-9 | In distribution | |
| XY-ZZJ-0B-2.5-1250-135-16 | In distribution | |
| XY-ZZJ-0A-2.5-1250-135-9 | In distribution | |
| XY-ZZJ-1A-2.5-1650-90-13 | In distribution | |
| XY-ZZJ-0B-2.5-1250-135-9 | In distribution | |
| XY-ZZJ-0A-2.5-2700-90-11 | In distribution | |
| XY-ZZJ-1B-2.5-2700-135-11 | In distribution | |
| XY-ZZJ-0A-2.5-2350-135-13 | In distribution | |
| XY-ZZJ-0B-2.5-1650-135-9 | In distribution | |
| XY-ZZJ-1A-2.5-1950-90-9 | In distribution | |
| XY-ZZJ-0B-2.5-1650-90-16 | In distribution | |
| XY-ZZJ-1A-2.5-1950-135-13 | In distribution | |
| XY-ZZJ-0B-2.5-2350-135-13 | In distribution | |
| XY-ZZJ-1A-2.5-1250-90-16 | In distribution | |
| XY-ZZJ-0B-2.5-2350-90-16 | In distribution | |
| XY-ZZJ-0A-2.5-2700-135-16 | In distribution | |
| XY-ZZJ-0A-2.5-2700-135-13 | In distribution | |
| XY-ZZJ-1A-2.5-1250-90-9 | In distribution | |
| XY-ZZJ-0A-2.5-1650-90-9 | In distribution | |
| XY-ZZJ-0B-2.5-1650-135-11 | In distribution | |
| XY-ZZJ-1B-2.5-1950-90-16 | In distribution | |
| XY-ZZJ-1B-2.5-1950-90-9 | In distribution | |
| XY-ZZJ-0A-2.5-2350-90-9 | In distribution | |
| XY-ZZJ-0B-2.5-1950-90-11 | In distribution | |
| XY-ZZJ-0B-2.5-2700-135-16 | In distribution | |
| XY-ZZJ-0A-2.5-1250-135-13 | In distribution | |
| XY-ZZJ-0A-2.5-2700-90-9 | In distribution | |
| XY-ZZJ-1A-2.5-1250-135-16 | In distribution | |
| XY-ZZJ-0A-2.5-1950-90-13 | In distribution | |
| XY-ZZJ-0A-2.5-2700-135-9 | In distribution | |
| XY-ZZJ-0A-2.5-1250-90-11 | In distribution | |
| XY-ZZJ-1A-2.5-1250-135-9 | In distribution | |
| XY-ZZJ-0B-2.5-2350-90-9 | In distribution | |
| XY-ZZJ-0A-2.5-1950-135-13 | In distribution | |
| XY-ZZJ-1A-2.5-2700-90-11 | In distribution | |
| XY-ZZJ-0B-2.5-1650-90-9 | In distribution | |
| XY-ZZJ-0A-2.5-1250-90-13 | In distribution | |
| XY-ZZJ-1B-2.5-2350-135-11 | In distribution | |
| XY-ZZJ-0A-2.5-1650-135-9 | In distribution | |
| XY-ZZJ-1B-2.5-2350-90-16 | In distribution | |
| XY-ZZJ-0B-2.5-1650-90-11 | In distribution | |
| XY-ZZJ-1B-2.5-1950-135-16 | In distribution | |
| XY-ZZJ-0A-2.5-1250-90-9 | In distribution | |
| XY-ZZJ-1A-2.5-1650-135-11 | In distribution | |
| XY-ZZJ-1B-2.5-1650-90-13 | In distribution | |
| XY-ZZJ-1A-2.5-1950-135-9 | In distribution | |
| XY-ZZJ-1A-2.5-1950-90-11 | In distribution | |
| XY-ZZJ-0B-2.5-2700-90-13 | In distribution | |
| XY-ZZJ-0B-2.5-2350-90-13 | In distribution | |
| XY-ZZJ-1A-2.5-1950-135-11 | In distribution | |
| XY-ZZJ-1B-2.5-1250-135-11 | In distribution | |
| XY-ZZJ-0B-2.5-1950-90-9 | In distribution | |
| XY-ZZJ-1A-2.5-1950-90-13 | In distribution | |
| XY-ZZJ-0A-2.5-2700-90-13 | In distribution | |
| XY-ZZJ-1B-2.5-2700-135-13 | In distribution | |
| XY-ZZJ-1B-2.5-1650-135-13 | In distribution | |
| XY-ZZJ-0B-2.5-1250-90-16 | In distribution | |
| XY-ZZJ-1A-2.5-2350-135-9 | In distribution | |
| XY-ZZJ-1A-2.5-2700-135-11 | In distribution | |
| XY-ZZJ-0B-2.5-1250-135-13 | In distribution | |
| XY-ZZJ-1A-2.5-1650-135-16 | In distribution | |
| XY-ZZJ-0B-2.5-2700-90-16 | In distribution | |
| XY-ZZJ-1A-2.5-1650-135-9 | In distribution | |
| XY-ZZJ-1B-2.5-2700-90-11 | In distribution | |
| XY-ZZJ-1A-2.5-1650-135-13 | In distribution | |
| XY-ZZJ-1B-2.5-1250-135-16 | In distribution | |
| XY-ZZJ-0A-2.5-2700-90-16 | In distribution | |
| XY-ZZJ-0A-2.5-2350-135-11 | In distribution | |
| XY-ZZJ-1B-2.5-1250-90-16 | In distribution | |
| XY-ZZJ-0B-2.5-1650-135-16 | In distribution | |
| XY-ZZJ-0B-2.5-1650-135-13 | In distribution | |
| XY-ZZJ-0B-2.5-1950-135-13 | In distribution | |
| XY-ZZJ-1B-2.5-2700-90-16 | In distribution | |
| XY-ZZJ-0A-2.5-1650-90-13 | In distribution | |
| XY-ZZJ-1A-2.5-2700-90-9 | In distribution | |
| XY-ZZJ-0A-2.5-1250-90-16 | In distribution | |
| XY-ZZJ-0A-2.5-2350-90-16 | In distribution | |
| XY-ZZJ-1A-2.5-1250-135-11 | In distribution | |
| XY-ZZJ-1B-2.5-1950-135-11 | In distribution | |
| XY-ZZJ-0B-2.5-2700-135-13 | In distribution | |
| XY-ZZJ-1B-2.5-2350-135-13 | In distribution | |
| XY-ZZJ-1A-2.5-1950-90-16 | In distribution | |
| XY-ZZJ-0A-2.5-1950-90-11 | In distribution | |
| XY-ZZJ-1A-2.5-1250-90-11 | In distribution | |
| XY-ZZJ-0B-2.5-1250-90-13 | In distribution | |
| XY-ZZJ-0B-2.5-1650-90-13 | In distribution | |
| XY-ZZJ-0B-2.5-2700-90-11 | In distribution | |
| XY-ZZJ-1B-2.5-1250-90-11 | In distribution | |
| XY-ZZJ-1A-2.5-2350-90-11 | In distribution | |
| XY-ZZJ-1B-2.5-2350-90-11 | In distribution | |
| XY-ZZJ-1A-2.5-2700-135-9 | In distribution | |
| XY-ZZJ-0A-2.5-2350-90-11 | In distribution | |
| XY-ZZJ-0B-2.5-2350-135-9 | In distribution | |
| XY-ZZJ-1A-2.5-1250-135-13 | In distribution | |
| XY-ZZJ-0A-2.5-2700-135-11 | In distribution | |
| XY-ZZJ-0B-2.5-1950-135-11 | In distribution | |
| XY-ZZJ-1A-2.5-2350-90-16 | In distribution | |
| XY-ZZJ-1A-2.5-2700-90-16 | In distribution | |
| XY-ZZJ-0A-2.5-2350-135-16 | In distribution | |
| XY-ZZJ-1B-2.5-1950-90-13 | In distribution | |
| XY-ZZJ-0A-2.5-1250-135-16 | In distribution | |
| XY-ZZJ-1B-2.5-1250-135-13 | In distribution | |
| XY-ZZJ-0B-2.5-1950-90-16 | In distribution | |
| XY-ZZJ-0A-2.5-1950-135-9 | In distribution | |
| XY-ZZJ-0A-2.5-2350-135-9 | In distribution | |
| XY-ZZJ-1A-2.5-1950-135-16 | In distribution | |
| XY-ZZJ-1B-2.5-1950-90-11 | In distribution | |
| XY-ZZJ-1A-2.5-2350-135-11 | In distribution | |
| XY-ZZJ-0B-2.5-2700-90-9 | In distribution | |
| XY-ZZJ-1B-2.5-2350-90-13 | In distribution | |
| XY-ZZJ-0A-2.5-2350-90-13 | In distribution | |
| XY-ZZJ-0A-2.5-1250-135-11 | In distribution | |
| XY-ZZJ-1B-2.5-1650-135-9 | In distribution | |
| XY-ZZJ-1A-2.5-2700-135-13 | In distribution | |
| XY-ZZJ-1B-2.5-2350-135-16 | In distribution | |
| XY-ZZJ-1B-2.5-1250-135-9 | In distribution | |
| XY-ZZJ-1A-2.5-2700-90-13 | In distribution | |
| XY-ZZJ-1A-2.5-2350-135-13 | In distribution | |
| XY-ZZJ-1B-2.5-2700-135-16 | In distribution | |
| XY-ZZJ-1B-2.5-2350-90-9 | In distribution | |
| XY-ZZJ-1B-2.5-1250-90-13 | In distribution | |
| XY-ZZJ-1B-2.5-1650-90-11 | In distribution | |
| XY-ZZJ-0A-2.5-1650-135-13 | In distribution | |
| XY-ZZJ-1B-2.5-1650-135-11 | In distribution | |
| XY-ZZJ-1A-2.5-2350-90-9 | In distribution | |
| XY-ZZJ-1A-2.5-1650-90-11 | In distribution | |
| XY-ZZJ-0B-2.5-2700-135-11 | In distribution | |
| XY-ZZJ-1B-2.5-2350-135-9 | In distribution | |
| XY-ZZJ-1B-2.5-1650-90-9 | In distribution | |
| XY-ZZJ-0B-2.5-1950-90-13 | In distribution | |
| XY-ZZJ-0A-2.5-1650-135-16 | In distribution | |
| XY-ZZJ-0A-2.5-1950-135-16 | In distribution | |
| XY-ZZJ-0A-2.5-1950-135-11 | In distribution | |
| XY-ZZJ-1B-2.5-1650-135-16 | In distribution | |
| XY-ZZJ-0A-2.5-1950-90-9 | In distribution | |
| XY-ZZJ-1A-2.5-1250-90-13 | In distribution | |
| XY-ZZJ-0A-2.5-1650-90-11 | In distribution | |
| XY-ZZJ-1A-2.5-2350-90-13 | In distribution | |
| XY-ZZJ-1B-2.5-1250-90-9 | In distribution | |
| XY-ZZJ-1B-2.5-2700-135-9 | In distribution | |
| XY-ZZJ-0B-2.5-2350-90-11 | In distribution | |
| XY-ZZJ-1B-2.5-2700-90-9 | In distribution | |
| XY-ZZJ-1B-2.5-2700-90-13 | In distribution | |
| XY-ZZJ-0B-2.5-1950-135-16 | In distribution | |
| XY-ZZJ-0B-2.5-1250-90-11 | In distribution | |
| XY-ZZJ-0A-2.5-1650-135-11 | In distribution | |
| XY-ZZJ-1B-2.5-1950-135-13 | In distribution | |
| XY-ZZJ-1A-2.5-1650-90-16 | In distribution | |
| XY-ZZJ-0A-2.5-1950-90-16 | In distribution | |
| XY-ZZJ-0A-2.5-1650-90-16 | In distribution | |
| XY-ZZJ-0B-2.5-1250-135-11 | In distribution | |
| XY-ZZJ-1B-2.5-1650-90-16 | In distribution | |
| XY-ZZJ-1A-2.5-1650-90-9 | In distribution | |
| XY-ZZJ-1B-2.5-1950-135-9 | In distribution | |
| XY-ZZJ-0B-2.5-2350-135-11 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hemostatic Metal Clip For The Gi Tract | Hangzhou AGS MedTech Co., Ltd. | 368 |
| 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 |
| 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 |
|---|---|
| K232969 | 2024-06-07 |
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.