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510(k) K252111

Device
Versius Surgical System (Versius Plus)
Applicant
Cmr Surgical Limited
510(k) number
K252111
Product code
SCV
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-16
Date received
2025-07-07
Regulation
878.4964
Classification name
Modular Electromechanical Surgical System
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Robert Lally
Address
1 Evolution Business Park, Milton Rd. Cambridge GB CB24 9NG CB24 9NG

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SCV#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250725Hugo™ RAS SystemCovidien, LLC2025-12-03
DEN230078Versius Surgical SystemCmr Surgical Limited2024-10-11