SCV · Class II · 21 CFR 878.4964

FDA Product Code SCV: Modular Electromechanical Surgical System

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.

Leading manufacturers include Cmr Surgical Limited and Covidien, LLC.

4
Total
3
Cleared
222d
Avg days
2024
Since
Growing category - 4 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Modular Electromechanical Surgical System Devices (Product Code SCV)

4 devices
1–4 of 4
Cleared Dec 16, 2025
Versius Surgical System (Versius Plus)
K252111
Cmr Surgical Limited
General & Plastic Surgery · 162d
Cleared Dec 03, 2025
Hugo™ RAS System
K250725
Covidien, LLC
General & Plastic Surgery · 268d
Not Cleared Oct 11, 2024
Versius Surgical System
DEN230078
Cmr Surgical Limited
General & Plastic Surgery · 325d

About Product Code SCV - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code SCV since 2024, with 3 receiving FDA clearance (average review time: 222 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.