Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4965
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.