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.
FDA 510(k) Cleared Modular Electromechanical Surgical System Devices (Product Code SCV)
About Product Code SCV - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code SCV since 2024, with 2 receiving FDA clearance (average review time: 252 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SCV devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →