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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Modular Electromechanical Surgical System
510(k) Number K252111
Device Name Versius Surgical System (Versius Plus)
Applicant
Cmr Surgical Limited
1 Evolution Business Park, Milton Rd.
Cambridge,  GB CB24 9NG
Applicant Contact Robert Lally
Correspondent
Daniel & Daniel Consulting
P.O. Box 129
Minden,  NV  89423
Correspondent Contact Michael Daniel
Classification Product Code
SCV  
Date Received07/07/2025
Decision Date 12/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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