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Electromechanical System For Open Microsurgery

FDA product code SAQ · 4 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4963
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-01-27 – 2025-11-10

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.

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