510(k) K242157

Anovo Surgical System (Model 6Ne) by Momentis Surgical , Ltd. — Product Code QNM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 21, 2024
Date Received: July 23, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mountable Electromechanical Surgical System For Transluminal Approaches
Device Class: Class II
Regulation Number: 878.4961
Review Panel: SU
Submission Type

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.

Other clearances by Momentis Surgical , Ltd.

K251761 — Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo (July 8, 2025)
K250591 — Anovo Surgical System (6Ne) (June 6, 2025)
K251056 — Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (May 2, 2025)
K243182 — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (February 3, 2025)
K241907 — Anovo Surgical System (model 6N) (October 2, 2024)
K232146 — Anovo Pedestal (September 14, 2023)
DEN190022 — Hominis Surgical System (February 26, 2021)

Other clearances for product code QNM

K251761 — Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo (July 8, 2025)
K250591 — Anovo Surgical System (6Ne) (June 6, 2025)
K251056 — Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (May 2, 2025)
K243182 — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (February 3, 2025)
K241907 — Anovo Surgical System (model 6N) (October 2, 2024)
K232146 — Anovo Pedestal (September 14, 2023)
DEN190022 — Hominis Surgical System (February 26, 2021)