inforMED
QNMClass II

Mountable Electromechanical Surgical System For Transluminal Approaches

General, Plastic Surgery · 21 CFR 878.4961

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.

MDR events3All time
Recalls0All time
Registered firms10Currently listed
510(k) clearances8All time

Event type breakdown

Injury2
Malfunction1

Recalls

0 recall events for this product code

See all →

No recalls on file for this product code.