Not Cleared Direct

Hominis Surgical System (DEN190022) - FDA 510(k) Clearance

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

DEN190022 · Momentis Surgical , Ltd. · General & Plastic Surgery device
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Feb 2021
Decision
681d
Days
Class 2
Risk

DEN190022 is an FDA 510(k) submission (not cleared) for the Hominis Surgical System. 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 Not Cleared (DENG) decision on February 26, 2021 after a review of 681 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 681 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Momentis Surgical , Ltd. devices

Submission Details

510(k) Number DEN190022 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 17, 2019
Decision Date February 26, 2021
Days to Decision 681 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
566d slower than avg
Panel avg: 115d · This submission: 681d
Pathway characteristics

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.