Home / 510(k) Clearances / DEN230078

510(k) DEN230078

Versius Surgical System by Cmr Surgical Limited — Product Code SCV

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 11, 2024
Date Received
November 21, 2023
Clearance Type
Direct
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

  • K252111 — Versius Surgical System (Versius Plus) (December 16, 2025)

Other clearances for product code SCV

  • K252111 — Versius Surgical System (Versius Plus) (December 16, 2025)
  • K250725 — Hugo™ RAS System (December 3, 2025)