Not Cleared Direct

DEN230025 - MIRA 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.

DEN230025 · Virtual Incision · General & Plastic Surgery device
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Feb 2024
Decision
318d
Days
Class 2
Risk

DEN230025 is an FDA 510(k) submission (not cleared) for the MIRA Surgical System. Classified as Table Mounted Miniaturized Electromechanical Surgical System (product code SAB), Class II - Special Controls.

Submitted by Virtual Incision (Lincoln, US). The FDA issued a Not Cleared (DENG) decision on February 23, 2024 after a review of 318 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4962 - 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 318 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.

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Submission Details

510(k) Number DEN230025 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 11, 2023
Decision Date February 23, 2024
Days to Decision 318 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
204d slower than avg
Panel avg: 114d · This submission: 318d
Pathway characteristics

Device Classification

Product Code SAB Table Mounted Miniaturized Electromechanical Surgical System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4962
Definition A Table Mounted Miniaturized Electromechanical Surgical System Is A Software-controlled Electromechanical System With Surgical Table Mounted Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures Where The Software-controlled Electromechanical Device’s Miniaturized And Compact Size Allows The Effective Element Of The System To Be Inserted Into The Body Cavity And Use Surgical Instruments Attached To The Electromechanical Arms
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.