QNM

8 FDA 510(k) clearances · Product code

FDA profile

Official device name

Mountable Electromechanical Surgical System For Transluminal Approaches

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4961

Medical specialty

General, Plastic Surgery

FDA definition

A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.

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