Cleared Special

K143426 - Wound Matrix TF

K143426 · Miromatrix Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Miromatrix Medical, Inc. devices

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

All 105
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K143426.
Collagen Dental Wound Dressings
K152600 · Collagen Matrix, Inc. · Jun 2016
MicroMatrix
K153754 · Acell, Inc. · Mar 2016
Cytal Wound Matrix
K152721 · Acell, Inc. · Dec 2015
Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
K142712 · Novabone Products, LLC · Jan 2015
COLLAGEN DENTAL WOUND DRESSINGS
K122115 · Collagen Matrix, Inc. · Nov 2012
INTEGRA WOUND MATRIX (THIN)
K113104 · Integra LifeSciences Corporation · Feb 2012