Cleared Traditional

K021637 - ACELL UBM LYOPHILIZED WOUND DRESSING

K021637 · Acell, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2002
Decision
216d
Days
-
Risk

K021637 is an FDA 510(k) clearance for the ACELL UBM LYOPHILIZED WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Acell, Inc. (Washington, US). The FDA issued a Cleared decision on December 19, 2002 after a review of 216 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Acell, Inc. devices

Submission Details

510(k) Number K021637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2002
Decision Date December 19, 2002
Days to Decision 216 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 115d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 85
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K021637.
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040558 · Collagen Matrix, Inc. · Mar 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040211 · Collagen Matrix, Inc. · Feb 2004
COLLAGEN TOPICAL WOUND DRESSING
K030921 · Collagen Matrix, Inc. · May 2003
SIGNADRESS DUODERM DRESSING
K990964 · Convatec, A Division of E.R. Squibb & Sons · May 1999
HA ABSORBENT WOUND DRESSING
K984388 · Convatec, A Division of E.R. Squibb & Sons · Mar 1999
FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
K982597 · Johnson & Johnson Medical, Inc. · Aug 1998