SAB

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Table Mounted Miniaturized Electromechanical Surgical System

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4962

Medical specialty

General, Plastic Surgery

FDA definition

A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical device’s miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms

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