The following data is part of a premarket notification filed by Cipher Surgical Limited with the FDA for 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-.
| Device ID | K221824 |
| 510k Number | K221824 |
| Device Name: | 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- |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Cipher Surgical Limited The Venture Centre, Sir William Lyons Road Coventry, GB CV4 7EZ |
| Contact | Justin Buch |
| Correspondent | Krupa Srivastava Cipher Surgical Limited The Venture Centre, Sir William Lyons Road Coventry, GB CV4 7EZ |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-23 |
| Decision Date | 2022-08-19 |