Product code SCV

Device name

Modular Electromechanical Surgical System

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4964

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset