Torrent
The Torrent irrigation scope connector Pentax is used with the Torrent irrigation tubing to provide irrigation fluids such as sterile water during gastrointestinal endoscopic procedures…
The Torrent irrigation scope connector Pentax is used with the Torrent irrigation tubing to provide irrigation fluids such as sterile water during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump (or electrosurgical unit).
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (3), Chongqing (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou | Jiangsu | Repacker / relabeller | 13 |
| Chongqing Jinshan Science & Technology (Group) Co., Ltd. | Chongqing | Chongqing | Manufacturer | 4 |
Record
| Listed by | Us Endoscopy, United States |
|---|---|
| FDA product code | OCX |
| Device type | Endoscopic Irrigation/Suction System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K140405 |
| Record published | 2016-09-17 |
| Record revised | 2022-06-10 (version 7) |
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 |
| Storage | Storage environment temperature 15 to 25 °C |
| Packaging | Box of 25, case of 100, case of 25, box of 10, carton of 50, box of 100 |
| Distribution end date | 2026-01-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00711561 | Withdrawn | |
| 00711570 | Withdrawn | |
| 00711561 | Withdrawn | |
| 00711562 | Withdrawn | |
| 00711560 | Withdrawn | |
| 00711571 | Withdrawn | |
| 00711562 | Withdrawn | |
| 00711563 | Withdrawn | |
| 00711570 | Withdrawn | |
| 00711571 | Withdrawn | |
| 00711570 | Withdrawn | |
| 00711571 | Withdrawn | |
| 00711563 | Withdrawn | |
| 00711560 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endogator Kit | Medivators Inc | 37 |
| Clean Connecting Tube | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 21 |
| Erbe | Erbe Elektromedizin GmbH | 19 |
| Endogator | Medivators Inc | 18 |
| ClearCap Distal Attachment | Finemedix | 14 |
| EndoGator Hybrid | Medivators Inc | 13 |
| Endoscopic Irrigation/Suction System | Pentax of America, Inc. | 12 |
| Reveal | Us Endoscopy | 12 |
| Endogator hybrid irrigation tubing | Medivators Inc | 10 |
| Erbeflo® 2 | Erbe Medical, LLC | 9 |
| BullDog® | Diversatek Healthcare Inc | 9 |
| Olympus | Keymed (Medical & Industrial Equipment) Ltd | 8 |
Showing 12 of 123. All products under Endoscopic Irrigation/Suction System
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| United States Endoscopy Group, Inc. | 510(k) number | 2013-03-07 | Class II | Device Design | The firm was notified by their customers that there was a water leakage from the white tubing connector. | 21,189 units | 2014-03-20 |
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.