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510(k) K252111

Versius Surgical System (Versius Plus) by Cmr Surgical Limited — Product Code SCV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2025
Date Received
July 7, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Modular Electromechanical Surgical System
Device Class
Class II
Regulation Number
878.4964
Review Panel
SU
Submission Type

A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.

Other clearances by Cmr Surgical Limited

  • DEN230078 — Versius Surgical System (October 11, 2024)

Other clearances for product code SCV

  • K250725 — Hugo™ RAS System (December 3, 2025)
  • DEN230078 — Versius Surgical System (October 11, 2024)