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510(k) K243182

Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode by Momentis Surgical , Ltd. — Product Code QNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2025
Date Received
September 30, 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)
  • K242157 — Anovo Surgical System (Model 6Ne) (October 21, 2024)
  • 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)
  • K242157 — Anovo Surgical System (Model 6Ne) (October 21, 2024)
  • K241907 — Anovo Surgical System (model 6N) (October 2, 2024)
  • K232146 — Anovo Pedestal (September 14, 2023)
  • DEN190022 — Hominis Surgical System (February 26, 2021)