Cleared Special

K251761 - Anovo Surgical System (Model 6Ne) (FDA 510(k) Clearance)

Also includes:
Anovo Instrument ARM Curved Scissors Anovo Instrument ARM Hook Electrode

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251761 · Momentis Surgical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
29d
Days
Class 2
Risk

K251761 is an FDA 510(k) clearance for the Anovo Surgical System (Model 6Ne). Classified as Mountable Electromechanical Surgical System For Transluminal Approaches (product code QNM), Class II - Special Controls.

Submitted by Momentis Surgical , Ltd. (Or Yehuda, IL). The FDA issued a Cleared decision on July 8, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4961 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Momentis Surgical , Ltd. devices

Submission Details

510(k) Number K251761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2025
Decision Date July 08, 2025
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 114d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QNM Mountable Electromechanical Surgical System For Transluminal Approaches
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4961
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QNM Mountable Electromechanical Surgical System For Transluminal Approaches

All 7
Devices cleared under the same product code (QNM) and FDA review panel - the closest regulatory comparables to K251761.
Anovo Surgical System (6Ne)
K250591 · Momentis Surgical , Ltd. · Jun 2025
Anovo Instrument ARM Curved Scissors
K251056 · Momentis Surgical , Ltd. · May 2025
Anovo Instrument ARM Curved Scissors
K243182 · Momentis Surgical , Ltd. · Feb 2025
Anovo Surgical System (Model 6Ne)
K242157 · Momentis Surgical , Ltd. · Oct 2024
Anovo Surgical System (model 6N)
K241907 · Momentis Surgical , Ltd. · Oct 2024
Anovo Pedestal
K232146 · Momentis Surgical , Ltd. · Sep 2023