510(k) K221824 ยท OCX Endoscopic Irrigation/Suction System
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
| Applicant | Cipher Surgical Limited, Coventry, GB |
| Decision | Substantially Equivalent, Aug 19, 2022 |
| Received | Jun 23, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221824
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.