CS-CU15-03 OpClear Control Unit
The OpClear Control Unit is a mains powered medical device which supplies, on demand, CO2 to the distal lens of the laparoscope via the OpClear Disposable. Includes a footswitch which is…
The OpClear Control Unit is a mains powered medical device which supplies, on demand, CO2 to the distal lens of the laparoscope via the OpClear Disposable. Includes a footswitch which is integral to the operation of the device.
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 | Cipher Surgical Ltd, United Kingdom |
|---|---|
| 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 |
| Record published | 2019-07-08 |
| Record revised | 2022-12-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -18 to 38 °C; Storage environment temperature -18 to 38 °C |
| Packaging | Carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS-CU15-03 | 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 |
|---|---|
| K221824 | 2022-08-19 |
| K171637 | 2018-02-26 |
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.