Cleared Special

Cytal Wound Matrix

K152721 · Acell, Inc. · General & Plastic Surgery
Dec 2015
Decision
78d
Days
Risk

About This 510(k) Submission

K152721 is an FDA 510(k) clearance for the Cytal Wound Matrix, a Wound Dressing With Animal-derived Material(s), submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on December 8, 2015, 78 days after receiving the submission on September 21, 2015. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K152721 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2015
Decision Date December 08, 2015
Days to Decision 78 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