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Table Mounted Miniaturized Electromechanical Surgical System

FDA product code SAB · 1 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4962
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-08-20 – 2026-08-20

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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