Table Mounted Miniaturized Electromechanical Surgical System
SAB · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4962
Classification
FDA Product Code
SAB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4962
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 table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical devices miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms