Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
SDD · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4965
Classification
FDA Product Code
SDD
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4965
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.