Cleared Special

K160400 - Miromatrix Biological Mesh (FDA 510(k) Clearance)

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

K160400 · Miromatrix Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
117d
Days
Class 2
Risk

K160400 is an FDA 510(k) clearance for the Miromatrix Biological Mesh. Classified as Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (product code OXH), Class II - Special Controls.

Submitted by Miromatrix Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on June 8, 2016 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Miromatrix Medical, Inc. devices

Submission Details

510(k) Number K160400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2016
Decision Date June 08, 2016
Days to Decision 117 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 114d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.
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.