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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name modular electromechanical surgical system
De Novo Number DEN230078
Device Name Versius Surgical System
Requester
cmr surgical limited
1 evolution business park
milton rd.
cambridge,  GB cb24 9ng
Contact chris weatherall
Regulation Number878.4964
Classification Product Code
SCV  
Date Received11/21/2023
Decision Date 10/11/2024
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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