Cleared Special

K092926 - ACELL MATRISTEM WOUND SHEET

K092926 · Acell, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
35d
Days
-
Risk

K092926 is an FDA 510(k) clearance for the ACELL MATRISTEM WOUND SHEET. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on October 28, 2009 after a review of 35 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 Acell, Inc. devices

FDA 510(k) Submission Details - K092926

510(k) Number K092926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2009
Decision Date October 28, 2009
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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 151
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K092926.
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ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009
PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440 · Tei Biosciences, Inc. · Dec 2008
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · Integra Lifesciences Corp. · Dec 2008