SCV — Modular Electromechanical Surgical System Class II

FDA Device Classification

Classification Details

Product Code: SCV
Device Class: Class II
Regulation Number: 878.4964
Submission Type
Review Panel: SU
Medical Specialty: General, Plastic Surgery
Implant: No

Definition

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K252111	cmr surgical limited	Versius Surgical System (Versius Plus)	December 16, 2025
K250725	covidien	Hugo RAS System	December 3, 2025
DEN230078	cmr surgical limited	Versius Surgical System	October 11, 2024