Cleared Traditional

K021637 - ACELL UBM LYOPHILIZED WOUND DRESSING

K021637 · Acell, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K021637

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 115d · This submission: 216d
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 151
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K021637.
DRESSSKIN
K023778 · Tei Biosciences, Inc. · Sep 2003
COLLAGEN TOPICAL WOUND DRESSING
K030921 · Collagen Matrix, Inc. · May 2003
ACELL UBM HYDRATED WOUND DRESSING
K022854 · Acell, Inc. · Dec 2002
AVAGEN WOUND DRESSING
K022127 · Integra Lifesciences Corp. · Sep 2002
BILAYER MATRIX WOUND DRESSING
K021792 · Integra Lifesciences Corp. · Aug 2002
SS MATRIX
K020732 · Cook Biotech, Inc. · May 2002