510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252111Substantially Equivalent

Versius Surgical System (Versius Plus)

CMR Surgical Inc., Cambridge, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252111 is the FDA 510(k) clearance record for Versius Surgical System (Versius Plus), a class II device, cleared for Cmr Surgical Limited on under FDA product code SCV (Modular Electromechanical Surgical System). FDA's definition for product code SCV reads: "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...". FDA records list 2 510(k) clearances for Cmr Surgical Limited, from to . As of , FDA records show one recall naming K252111.

Clearance record

Decision date
Received
(162 days to decision)
Product code
SCV Modular Electromechanical Surgical System
Regulation
21 CFR 878.4964
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cmr Surgical Limited 1 Evolution Business Park, Milton Rd., Cambridge, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SCV

Trailing 12 months
3 clearances under product code SCV in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code SCV, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260