inforMED
SDDClass II

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

General, Plastic Surgery · 21 CFR 878.4965

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.

MDR events3All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances4All time

Event type breakdown

Malfunction3

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