SDD

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4965

Medical specialty

General, Plastic Surgery

FDA definition

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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