SCV

Modular Electromechanical Surgical System

Product code: SCV
Device name: Modular Electromechanical Surgical System
Device class: Class 2
21 CFR: 21 CFR 878.4964
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 4

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-07-22.

Number	Decision date	Applicant	Device name	Summary
K260804	2026-07-22	Momentis Surgical , Ltd.	Anovo Surgical System (6Ne)	PDF
K252111	2025-12-16	Cmr Surgical Limited	Versius Surgical System (Versius Plus)	PDF
K250725	2025-12-03	Covidien, LLC	Hugo RAS System	PDF
DEN230078	2024-10-11	Cmr Surgical Limited	Versius Surgical System	—

3 summaries are archived here for direct download.

Official FDA classification page: SCV

Classification and pathway per current FDA publications. Data from openFDA (CC0).