KGN

FDA Product Code KGN: Wound Dressing With Animal-derived Material(s)

Biologically derived wound care materials leverage the regenerative properties of natural extracellular matrix. FDA product code KGN covers wound dressings containing animal-derived materials — such as collagen, chitosan, or decellularized tissue matrices.

These dressings provide a biologically active scaffold that promotes cellular migration, granulation tissue formation, and wound closure. They are used in chronic wounds, burns, and surgical defects where conventional dressings are insufficient.

KGN devices are reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Acell, Inc., Collagen Matrix, Inc. and Kerecis Limited.

191
Total
191
Cleared
155d
Avg days
1979
Since
191 devices
121–144 of 191
Cleared Dec 12, 2008
PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440
Tei Biosciences, Inc.
General & Plastic Surgery · 22d
Cleared Dec 04, 2008
INTEGRA MESHED BILAYER WOUND MATRIX
K081635
Integra Lifesciences Corp.
General & Plastic Surgery · 176d
Cleared Oct 10, 2007
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113
Integra Lifesciences Corp.
General & Plastic Surgery · 70d
Cleared Jul 19, 2006
OASIS WOUND MATRIX
K061711
Cook Biotech, Inc.
General & Plastic Surgery · 30d
Cleared Jun 29, 2006
PRIMATRIX DERMAL REPAIR SCAFFOLD
K061407
Tei Biosciences, Inc.
General & Plastic Surgery · 38d
Cleared Jun 23, 2006
ACELL POWDER WOUND DRESSING
K060888
Acell, Inc.
General & Plastic Surgery · 84d
Cleared Jun 19, 2006
MEDLINE COLLAGEN WOUND DRESSING
K060456
Medline Industries, Inc.
General & Plastic Surgery · 117d
Cleared Apr 27, 2005
COLACTIVE COLLAGEN WOUND DRESSING
K050177
Covalontechnologies, Inc.
General & Plastic Surgery · 91d
Cleared May 10, 2004
COLLAGEN WOUND DRESSING - ORAL
K040403
Collagen Matrix, Inc.
General & Plastic Surgery · 83d
Cleared Mar 17, 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040558
Collagen Matrix, Inc.
General & Plastic Surgery · 14d
Cleared Feb 27, 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040211
Collagen Matrix, Inc.
General & Plastic Surgery · 28d
Cleared Sep 29, 2003
DRESSSKIN
K023778
Tei Biosciences, Inc.
General & Plastic Surgery · 321d
Cleared May 15, 2003
COLLAGEN TOPICAL WOUND DRESSING
K030921
Collagen Matrix, Inc.
General & Plastic Surgery · 52d
Cleared Dec 30, 2002
ACELL UBM HYDRATED WOUND DRESSING
K022854
Acell, Inc.
General & Plastic Surgery · 137d
Cleared Dec 19, 2002
ACELL UBM LYOPHILIZED WOUND DRESSING
K021637
Acell, Inc.
General & Plastic Surgery · 216d
Cleared Sep 10, 2002
AVAGEN WOUND DRESSING
K022127
Integra Lifesciences Corp.
General & Plastic Surgery · 71d
Cleared Aug 14, 2002
BILAYER MATRIX WOUND DRESSING
K021792
Integra Lifesciences Corp.
General & Plastic Surgery · 75d
Cleared May 30, 2002
SS MATRIX
K020732
Cook Biotech, Inc.
General & Plastic Surgery · 85d
Cleared Apr 18, 2000
MEDTRADE PRODUCTS ALGINATE ISLAND
K000487
Medtrade Products , Ltd.
General & Plastic Surgery · 64d
Cleared Mar 22, 2000
HYCURE ORAL / HYCURE ORAL SMART GEL
K994339
The Hymed Group Corp.
General & Plastic Surgery · 90d
Cleared Jan 06, 2000
SIS WOUND DRESSING II
K993948
Cook Biotech, Inc.
General & Plastic Surgery · 45d
Cleared May 18, 1999
SIGNADRESS DUODERM DRESSING
K990964
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 56d
Cleared Mar 31, 1999
HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
K990086
Integra Lifesciences Corp.
General & Plastic Surgery · 79d
Cleared Mar 03, 1999
HA ABSORBENT WOUND DRESSING
K984388
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 85d