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Mountable Electromechanical Surgical System For Transluminal Approaches

FDA product code QNM · 7 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4961
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-09-14 – 2025-07-08

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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