K221824

Substantially Equivalent

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
Product code: OCX
Advisory panel: Gastroenterology, Urology
Date received: 2022-06-23
Decision date: 2022-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Coventry, GB

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