Cleared Traditional

K243182 - Anovo Instrument ARM Curved Scissors (FDA 510(k) Clearance)

Also includes:
Anovo Instrument ARM Hook Electrode

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

K243182 · Momentis Surgical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
126d
Days
Class 2
Risk

K243182 is an FDA 510(k) clearance for the Anovo Instrument ARM Curved Scissors. 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 February 3, 2025 after a review of 126 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 K243182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date February 03, 2025
Days to Decision 126 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
12d slower than avg
Panel avg: 114d · This submission: 126d
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 K243182.
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 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