Cleared Special

MicroMatrix

K153754 · Acell, Inc. · General & Plastic Surgery
Mar 2016
Decision
76d
Days
—
Risk

About This 510(k) Submission

K153754 is an FDA 510(k) clearance for the MicroMatrix, a Wound Dressing With Animal-derived Material(s), submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on March 14, 2016, 76 days after receiving the submission on December 29, 2015. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K153754 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2015
Decision Date March 14, 2016
Days to Decision 76 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 —