Andorate® 4-Piece Valve Kit
Catalogue number GAR066, listed by GA Health Company Limited, Hong Kong, under Endoscopic Irrigation/Suction System. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
11recalls on this code
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 | GA Health Company Limited, Hong Kong |
|---|---|
| FDA product code | OCX |
| Device type | Endoscopic Irrigation/Suction System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-01-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 50, carton of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GAR066 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231602 | 2023-08-01 |
| K230932 | 2023-07-07 |
| K223171 | 2022-11-10 |
| K202560 | 2020-12-10 |
| K200479 | 2020-05-15 |
| K200388 | 2020-04-14 |
Recalls
11 of these are 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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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.