Zutron Medical
Check valve, normally closed, non-sterile
10manufacturers in China registered for this device type
1catalogue number
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 | Zutron Medical, L.L.C. |
|---|---|
| FDA product code | OCX |
| Device type | Endoscopic Irrigation/Suction System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K181509 |
| Record published | 2023-09-21 |
| Record revised | 2024-04-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 100 |
| Distribution end date | 2024-04-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZUTR50523 | Withdrawn |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 |
| Torrent | Us Endoscopy | 14 |
| 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 |
Showing 12 of 123. All products under Endoscopic Irrigation/Suction System
Recalls Naming This Product
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 12,800 units | 2021-09-03 |
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 25,000 units | 2021-09-03 |
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 11,000 units | 2021-09-03 |
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 10,000 | 2021-09-03 |
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 6,470 units | 2021-09-03 |
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 93,700 units | 2021-09-03 |
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 50 units | 2021-09-03 |
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 20,000 units | 2021-09-03 |
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 20,000 units | 2021-09-03 |
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 100,000 units | 2021-09-03 |
| GA Health Company Limited | 510(k) number | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 10,000 units | 2021-09-03 |
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.