Dual Action Tissue Closure Device
The Dual Action Tissue Closure Device is an endoscopic clip system for compressing tissue in the gastrointestinal tract of adults. It combines a delivery system with a metallic clip…
The Dual Action Tissue Closure Device is an endoscopic clip system for compressing tissue in the gastrointestinal tract of adults. It combines a delivery system with a metallic clip component for use in flexible endoscopy.
Two operating handles control their corresponding clips. Pulling steel wire through a handle drives opening and closing of the clasping mechanism so it can grip tissue.
Listed Item
Open Width 12mm-15mm, Maximal Outer Diameter of the Insertion <2.8mmmm, Working Channel >=2.8mm, Without Lateral Teeth, Working Length(L2)1950±10%L2
Applications and Supply
The system supports endoscopic marking, hemostasis and supplementary closure of selected gastrointestinal perforations. It is a sterile, single-use device supplied in protective sterile packaging after ethylene-oxide sterilization. The delivery assembly carries the clip component to the target through the endoscopic setup.
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) | K250229 |
| Record published | 2025-09-30 |
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 20 |
| Sizes | Outer diameter 2.8 mm; length 1650 to 2350 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DAT0100E | Outer Diameter 2.8 mm | In distribution |
| DAT0100A | Outer Diameter 2.8 mm | In distribution |
| DAT0100B | Outer Diameter 2.8 mm | In distribution |
| DAT0100G | Outer Diameter 2.8 mm | In distribution |
| DAT01001 | Outer Diameter 2.8 mm | In distribution |
| DAT01000 | Outer Diameter 2.8 mm | In distribution |
| DAT01003 | Outer Diameter 2.8 mm | In distribution |
| DAT0100F | Outer Diameter 2.8 mm | In distribution |
| DAT01007 | Outer Diameter 2.8 mm | In distribution |
| DAT01002 | Outer Diameter 2.8 mm | In distribution |
| DAT01004 | Outer Diameter 2.8 mm | In distribution |
| DAT01006 | Outer Diameter 2.8 mm | In distribution |
| DAT0100H | Outer Diameter 2.8 mm | In distribution |
| DAT0100C | Outer Diameter 2.8 mm | In distribution |
| DAT01009 | Outer Diameter 2.8 mm | In distribution |
| DAT01005 | Outer Diameter 2.8 mm | In distribution |
| DAT0100D | Outer Diameter 2.8 mm | In distribution |
| DAT01008 | Outer Diameter 2.8 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 |
| 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.