Cleared Traditional

K241907 - Anovo Surgical System (model 6N) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K241907 · Momentis Surgical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
93d
Days
Class 2
Risk

K241907 is an FDA 510(k) clearance for the Anovo Surgical System (model 6N). 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 October 2, 2024 after a review of 93 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 K241907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2024
Decision Date October 02, 2024
Days to Decision 93 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
21d faster than avg
Panel avg: 114d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06457971 Recruiting Interventional Industry-sponsored

Anovo Surgical System in Ventral Hernia

Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia

50
Patients (est.)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Ventral Hernia
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Momentis Surgical (industry)
Started 2024-01-14 → Primary completion 2025-12-01
Primary outcome
Rate of Conversion
Secondary outcome
IntraOperative Procedural Outcomes - AE and SADE
View full study on ClinicalTrials.gov

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 K241907.
Anovo Surgical System (Model 6Ne)
K251761 · Momentis Surgical , Ltd. · Jul 2025
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 Pedestal
K232146 · Momentis Surgical , Ltd. · Sep 2023