QNM — Mountable Electromechanical Surgical System For Transluminal Approaches Class II

FDA Device Classification

Classification Details

Product Code
QNM
Device Class
Class II
Regulation Number
878.4961
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251761momentis surgicalAnovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo July 8, 2025
K250591momentis surgicalAnovo Surgical System (6Ne)June 6, 2025
K251056momentis surgicalAnovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook ElectrodeMay 2, 2025
K243182momentis surgicalAnovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook ElectrodeFebruary 3, 2025
K242157momentis surgicalAnovo Surgical System (Model 6Ne)October 21, 2024
K241907momentis surgicalAnovo Surgical System (model 6N)October 2, 2024
K232146momentis surgicalAnovo PedestalSeptember 14, 2023
DEN190022momentis surgicalHominis Surgical SystemFebruary 26, 2021