Integrated Operating Table-Electromechanical Surgical System
SIR · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4966
Classification
FDA Product Code
SIR
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4966
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 integrated operating table-electromechanical surgical system is a software-controlled electromechanical platform, consisting of a surgical table with integrated robotic arms and table motion capability, that enables a qualified user to perform surgical techniques during minimally invasive and laparoscopic surgical procedures. The surgical table can be used for open surgical procedures independent of the robotic platform.