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— 510(k) K221824

Name: FDA 510(k) clearance K221824
Creator: U.S. Food and Drug Administration
Published: 2022-08-19

Substantially Equivalent

Cipher Surgical Limited

FDA 510(k) clearance K221824 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-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315, Substantially Equivalent on 2022-08-19. Applicant: Cipher Surgical Limited. Device class: 2.

Clearance details

Applicant: Cipher Surgical Limited
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-06-23
Decision date: 2022-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Coventry, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.