S.t.a.r(TM) Disposable Hemostatic Closure Clip Device
The S.T.A.R. disposable hemostatic closure clip device places a clip during flexible gastrointestinal endoscopy to compress tissue. It can be used for endoscopic marking, control of…
The S.T.A.R. disposable hemostatic closure clip device places a clip during flexible gastrointestinal endoscopy to compress tissue. It can be used for endoscopic marking, control of selected bleeding lesions, and closure of luminal perforations smaller than 20 mm that can be treated conservatively.
A nickel-titanium clip is preloaded in a barrel on the delivery system. Negative pressure draws tissue into position, and the operator releases the clip using the handle. The system is supplied sterile for single patient use.
Listed Item
Clip Outer Diameter: φ17.0 mm, Working Length: 2350 mm, Endoscopy Dimension(φ): 11.5-14 mm, Outer Tube without Coating
Indication Limits
Bleeding indications include mucosal or submucosal defects smaller than 3 cm, bleeding ulcers, arteries smaller than 2 mm, polyps smaller than 1.5 cm, and colonic diverticula. The range includes 17 mm clips and 2350 mm working lengths, with coated and uncoated outer tubes.
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) | K220157 |
| Record published | 2022-12-31 |
| Record revised | 2025-12-11 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| 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 20 |
| Sizes | Length 1650 to 2700 mm; outer diameter 14.5 to 17 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HCCD-1-165-L-C | Length 1650 mm | In distribution |
| HCCD-1-270-L-C | Length 2700 mm | In distribution |
| HCCD-1-195-L-C | Length 1950 mm | In distribution |
| HCCD-0-235-M-C | Length 2350 mm | In distribution |
| HCCD-0-195-M-C | Length 1950 mm | In distribution |
| HCCD-0-270-M-C | Length 2700 mm | In distribution |
| HCCD-0-235-M | Length 2350 mm | In distribution |
| HCCD-0-270-L-C | Length 2700 mm | In distribution |
| HCCD-0-235-L-C | Length 2350 mm | In distribution |
| HCCD-0-195-L-C | Length 1950 mm | In distribution |
| HCCD-0-165-L-C | Length 1650 mm | In distribution |
| HCCD-0-195-M | Length 1950 mm | In distribution |
| HCCD-0-165-M-C | Length 1650 mm | In distribution |
| HCCD-1-235-L | Length 2350 mm | In distribution |
| HCCD-0-270-M | Length 2700 mm | In distribution |
| HCCD-0-270-L | Length 2700 mm | In distribution |
| HCCD-1-235-L-C | Length 2350 mm | In distribution |
| HCCD-0-195-L | Length 1950 mm | In distribution |
| HCCD-0-165-L | Length 1650 mm | In distribution |
| HCCD-1-270-L | Length 2700 mm | In distribution |
| HCCD-1-165-L | Length 1650 mm | In distribution |
| HCCD-0-235-L | Length 2350 mm | In distribution |
| HCCD-0-165-M | Length 1650 mm | In distribution |
| HCCD-1-195-L | Length 1950 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 |
| 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 |
|---|---|
| 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.