K221824 is an FDA 510(k) clearance for the 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. This device is classified as a Endoscopic Irrigation/suction System (Class II - Special Controls, product code OCX).
Submitted by Cipher Surgical Limited (Coventry, GB). The FDA issued a Cleared decision on August 19, 2022, 57 days after receiving the submission on June 23, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures..
| 510(k) Number | K221824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2022 |
| Decision Date | August 19, 2022 |
| Days to Decision | 57 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OCX - Endoscopic Irrigation/suction System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures. |