Otsc Anchor
The OTSC Anchor is one of the OTSC application aids • can be used for treating a lesion before release of the OTSC clip • can be used for better approximation of tissue especially when…
The OTSC Anchor is one of the OTSC application aids • can be used for treating a lesion before release of the OTSC clip • can be used for better approximation of tissue especially when indurated (e.g. fistulae, chronic ulcer) • facilitates targeting lesions, e.g. in the treatment of hemorrhage • allows precise alignment between the target tissue and the application cap • the head of the instrument is made of Nitinol • a working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| 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 |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
Showing 12 of 21. All 21 manufacturers in China registered for Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
Record
| Listed by | Ovesco Endoscopy AG, Germany |
|---|---|
| FDA product code | PTS |
| Device type | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-16 |
| Record revised | 2022-11-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 165 cm | needle width 12 mm / stich depth 4 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Hangzhou AGS MedTech Co., Ltd. | 106 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 72 |
| Captura | Cook Incorporated | 53 |
| Captura Pro | Cook Incorporated | 28 |
| Alton | Alton Shanghai Medical Instruments Co Ltd | 9 |
| Centra | Us Endoscopy | 4 |
| Disposable Grasping Forceps | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 4 |
| Seplou | Seplou (Zhuhai) Co., Ltd. | 3 |
| Single Use Loop Cutter FS-410 | Olympus Medical Systems Corp. | 3 |
| Anrei | Anrei Medical(HZ) Co., Ltd. | 2 |
| Histoguide wire guided forceps | Us Endoscopy | 2 |
| Cook | Cook Incorporated | 2 |
Showing 12 of 39. All products under Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
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.