Cleared Traditional

K250591 - Anovo Surgical System (6Ne) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250591 · Momentis Surgical , Ltd. · General & Plastic Surgery device
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Jun 2025
Decision
99d
Days
Class 2
Risk

K250591 is an FDA 510(k) clearance for the Anovo Surgical System (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 June 6, 2025 after a review of 99 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Momentis Surgical , Ltd. devices

Submission Details

510(k) Number K250591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2025
Decision Date June 06, 2025
Days to Decision 99 days
Submission Type Traditional
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
15d faster than avg
Panel avg: 114d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K250591.
Anovo Surgical System (Model 6Ne)
K251761 · Momentis Surgical , Ltd. · Jul 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