Cleared Traditional

K060888 - ACELL POWDER WOUND DRESSING

K060888 · Acell, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
84d
Days
-
Risk

K060888 is an FDA 510(k) clearance for the ACELL POWDER WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Acell, Inc. (Chevy Chase, US). The FDA issued a Cleared decision on June 23, 2006 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060888

510(k) Number K060888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2006
Decision Date June 23, 2006
Days to Decision 84 days
Submission Type Traditional
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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

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 182
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K060888.
OASIS WOUND MATRIX
K061711 · Cook Biotech, Inc. · Jul 2006
COLLAWOUND DRESSING
K061474 · Collamatrix Co., Inc. · Jul 2006
PRIMATRIX DERMAL REPAIR SCAFFOLD
K061407 · Tei Biosciences, Inc. · Jun 2006
MEDLINE COLLAGEN WOUND DRESSING
K060456 · Medline Industries, Inc. · Jun 2006
COLACTIVE COLLAGEN WOUND DRESSING
K050177 · Covalontechnologies, Inc. · Apr 2005
HEALICOLL
K040314 · Encoll Corp. · Aug 2004