SCV · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4964
Classification
FDA Product Code
SCV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4964
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.