DeviceClearance

Product code QNM— General, Plastic Surgery

Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode

Classification name
Mountable Electromechanical Surgical System For Transluminal Approaches
Device class
Class 2
Regulation
21 CFR 878.4961
Advisory panel
General, Plastic Surgery
Total cleared
8
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QNM under 21 CFR 878.4961, via openFDA

Market context for product code QNM

FDA has cleared 8 devices under product code QNM between 2021 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QNM

Recent clearances under product code QNM

Data sourced from openFDA. This site is unofficial and independent of the FDA.