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Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

FDA product code SDD · 4 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4965
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-05-27 – 2026-08-11

An electromechanical surgical system with transient sterile field presence of both surgeon and primary control interface is a software-controlled electromechanical system with fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures. The device allows for both the surgeon and primary control interface to have presence inside the sterile field as needed within the clinical context of use.

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