Product code SAQ

Device name

Electromechanical System For Open Microsurgery

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4963

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm.

Source

FDA openFDA device classification dataset