Cleared Special

Wound Matrix TF

K143426 · Miromatrix Medical, Inc. · General & Plastic Surgery
Jan 2015
Decision
57d
Days
Risk

About This 510(k) Submission

K143426 is an FDA 510(k) clearance for the Wound Matrix TF, a Wound Dressing With Animal-derived Material(s), submitted by Miromatrix Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 27, 2015, 57 days after receiving the submission on December 1, 2014. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K143426 FDA.gov
FDA Decision Cleared 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

Device Classification

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