Cleared Traditional

K260804 - Anovo Surgical System (6Ne)

K260804 is the FDA 510(k) clearance for Anovo Surgical System (6Ne) by Momentis Surgical , Ltd.. It is a Class 2 General & Plastic Surgery device (product code SCV) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K260804 · Momentis Surgical , Ltd. · General & Plastic Surgery device
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Jul 2026
Decision
132d
Days
Class 2
Risk

K260804 is an FDA 510(k) clearance for the Anovo Surgical System (6Ne). Classified as Modular Electromechanical Surgical System (product code SCV), Class II - Special Controls.

Submitted by Momentis Surgical , Ltd. (Or Yehuda, IL). The FDA issued a Cleared decision on July 22, 2026 after a review of 132 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4964 - 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 K260804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2026
Decision Date July 22, 2026
Days to Decision 132 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SCV Modular Electromechanical Surgical System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4964
Definition A Modular Electromechanical Surgical System Is A Software-controlled Electromechanical System With A Plurality Of Individual, Fully Positionable Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures.
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.