Cleared Special

K143426 - Wound Matrix TF

K143426 · Miromatrix Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
57d
Days
-
Risk

K143426 is an FDA 510(k) clearance for the Wound Matrix TF. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Miromatrix Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 27, 2015 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K143426

510(k) Number K143426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2014
Decision Date January 27, 2015
Days to Decision 57 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Consultant

Biologics Consulting Group, Inc.
Stephen Rhodes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 182
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K143426.
Cook ECM Powder
K152033 · Cook Biotech Incorporated · Aug 2015
XENOMEM WOUND MATRIX
K140820 · Viscus Biologics, LLC · Jun 2015
MEDEOR MATRIX WOUND DRESSING
K141738 · Kensey Nash Corporation Dba Dsm Biomedical · Feb 2015
KA01 Chitosan Wound Dressing
K143124 · Foshan United Medical Technologies, Ltd. · Jan 2015
Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
K142712 · Novabone Products, LLC · Jan 2015
ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
K140367 · Harbor Medtech, Inc. · Sep 2014