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Parker Quality & Compliance

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510(k) clearance

Versius Surgical System (Versius Plus)

FDA 510(k) source

510(k) number
K261252
Applicant
Cmr Surgical Limited
Decision date
Oct 21, 2026
Date received
Apr 16, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
SCV
Device type
Modular Electromechanical Surgical System
Device class
Class II
Regulation
21 CFR 878.4964
Advisory committee
General, Plastic Surgery
Statement or summary
Summary
Third party
N
Location
Cambridge, GB