Mountable Electromechanical Surgical System For Transluminal Approaches
QNM · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4961
Classification
FDA Product Code
QNM
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4961
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 mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.