Data / Medical devices / United Kingdom / Cipher Surgical Ltd
Cipher Surgical Ltd: FDA-registered device maker in Coventry, United Kingdom, 1 510(k) clearance
Cipher Surgical Ltd is registered with the FDA (registration 3013348547) in Coventry, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 19, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013348547
- Address
- The Venture Centre Sir William Lyons Road, Coventry, United Kingdom, CV4 7EZ
- Owner or operator
- Cipher Surgical Ltd (10060194)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 15, 2022
- Registered through
- 2026
- Brand names listed
- CS-CU15-03, OpClear®, OpClear® Control Unit, OpClear® Disposable, OpClear® Disposable Procedure Kit, OpClear® Platform, OpClear® System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Irrigation/Suction System | OCX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Air, Non-Manual, For Endoscope | FEQ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 2022 | K221824 | OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315 | OCX | Substantially Equivalent | Cipher Surgical Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Air, Non-Manual, For Endoscope
- All makers of Endoscopic Irrigation/Suction System
Updated August 19, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.