SwirlNet
Endoscopic Retrieval Net - Standard, Enteroscope
19manufacturers in China registered for this device type
6catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (5), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
Showing 12 of 19. All 19 manufacturers in China registered for Snare, Non-Electrical
Record
| Listed by | Endo-Therapeutics, Inc., United States |
|---|---|
| FDA product code | FGX |
| Device type | Snare, Non-Electrical |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Dry |
| Packaging | Box of 5, box of 10 |
| Sizes | Length 160 to 350 cm; outer diameter 1.8 to 3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ET2012 | Net Size: 3.0 cm x 6.0 cm | In distribution |
| ET2010 | Net Size: 2.0 cm x 4.5 cm | In distribution |
| ET2014 | Net Size: 4.0 cm x 8.0 cm | In distribution |
| ET2011 | Net Size: 3.0 cm x 6.0 cm | In distribution |
| ET2015 | Net Size: 4.0 cm x 8.0 cm | In distribution |
| ET2013 | Net Size: 3.0 cm x 6.0 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Snare, Non-Electrical | Hangzhou AGS MedTech Co., Ltd. | 262 |
| Disposable Cold Snares | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 8 |
| Disposable Polypectomy Cold Snare | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 6 |
| RotoNet | Endo-Therapeutics, Inc. | 6 |
| M-Catch | Diversatek Healthcare Inc | 4 |
| Lasso | Diversatek Healthcare Inc | 4 |
| Snare | Taewoongmedical.co., Ltd. | 4 |
| Optimos™ Snare | Taewoongmedical.co., Ltd. | 4 |
| EnTrap(TM) Polyp Retrieval Snare Net | Micro-Tech (Nanjing) Co., Ltd. | 4 |
| Polypectomy Snare | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 3 |
| Exacto | Us Endoscopy | 3 |
| Exacto Mundo | Us Endoscopy | 3 |
Showing 12 of 20. All products under Snare, Non-Electrical
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-10-24 | Class II | Other | Improper device regulatory classification | 28 devices | 2024-01-24 |
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.