CS-SR10-00 OpClear Disposable
The OpClear Disposable is a 10mm x00degree x 328mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which is fitted to a compatible laparoscope.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
Record
| Listed by | Cipher Surgical Ltd, United Kingdom |
|---|---|
| FDA product code | FEQ |
| Device type | Pump, Air, Non-Manual, For Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K171637 |
| Record published | 2019-07-08 |
| Record revised | 2022-07-04 (version 2) |
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 |
| Storage | Storage environment humidity 20 to 90 % RH; Storage environment temperature 5 to 25 °C |
| Packaging | Box carton of 10 |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS-SR10-00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Erbe | Erbe Elektromedizin GmbH | 24 |
| AquaShield | Us Endoscopy | 16 |
| Olympus | Keymed (Medical & Industrial Equipment) Ltd | 13 |
| Hydra | Boston Scientific Corporation | 13 |
| Erbeflo CleverCap® | Erbe Medical, LLC | 8 |
| Olympus | Olympus Winter & IBE Gmbh | 7 |
| Erbeflo AeroRinse® | Erbe Medical, LLC | 4 |
| Endogator | Medivators Inc | 4 |
| Defendo | Medivators Inc | 3 |
| Torrent and AquaShield | Us Endoscopy | 2 |
| CS-05-00-290 OpClear Disposable | Cipher Surgical Ltd | 1 |
| CS-10-00-300 OpClear Disposable | Cipher Surgical Ltd | 1 |
Showing 12 of 30. All products under Pump, Air, Non-Manual, For Endoscope
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.