QNM

Mountable Electromechanical Surgical System For Transluminal Approaches

Product code

QNM

Device name

Mountable Electromechanical Surgical System For Transluminal Approaches

Device class

Class 2

21 CFR

21 CFR 878.4961

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

8

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (7)

Last three years. Most recent: 2025-07-08.

7 summaries are archived here for direct download.