Not Cleared Direct

DEN230032 - Symani Surgical System (FDA 510(k) Clearance)

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

DEN230032 · Mmi North America, Inc. · General & Plastic Surgery device
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Apr 2024
Decision
346d
Days
Class 2
Risk

DEN230032 is an FDA 510(k) submission (not cleared) for the Symani Surgical System. Classified as Electromechanical System For Open Microsurgery (product code SAQ), Class II - Special Controls.

Submitted by Mmi North America, Inc. (Ponte Vedra, US). The FDA issued a Not Cleared (DENG) decision on April 5, 2024 after a review of 346 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4963 - 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 346 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 Mmi North America, Inc. devices

Submission Details

510(k) Number DEN230032 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 25, 2023
Decision Date April 05, 2024
Days to Decision 346 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
232d slower than avg
Panel avg: 114d · This submission: 346d
Pathway characteristics

Device Classification

Product Code SAQ Electromechanical System For Open Microsurgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4963
Definition An Electromechanical System For Open Microsurgery Is A Software-controlled Electromechanical System With Bedside Human/device Interfaces And Without An Integrated Visualization System Which Allows A Qualified User To Perform Surgical Techniques During Open Mircosurgical 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 - SAQ Electromechanical System For Open Microsurgery

Devices cleared under the same product code (SAQ) and FDA review panel - the closest regulatory comparables to DEN230032.
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