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
Cleared
Dec 12, 2008
PRIMATRIX DERMAL REPAIR SCAFFOLD
Tei Biosciences, Inc.
General & Plastic Surgery
22d
Cleared
Dec 04, 2008
INTEGRA MESHED BILAYER WOUND MATRIX
Integra Lifesciences Corp.
General & Plastic Surgery
176d
Cleared
Oct 10, 2007
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
Integra Lifesciences Corp.
General & Plastic Surgery
70d
Cleared
Jul 19, 2006
OASIS WOUND MATRIX
Cook Biotech, Inc.
General & Plastic Surgery
30d
Cleared
Jun 29, 2006
PRIMATRIX DERMAL REPAIR SCAFFOLD
Tei Biosciences, Inc.
General & Plastic Surgery
38d
Cleared
Jun 23, 2006
ACELL POWDER WOUND DRESSING
Acell, Inc.
General & Plastic Surgery
84d
Cleared
Jun 19, 2006
MEDLINE COLLAGEN WOUND DRESSING
Medline Industries, Inc.
General & Plastic Surgery
117d
Cleared
Apr 27, 2005
COLACTIVE COLLAGEN WOUND DRESSING
Covalontechnologies, Inc.
General & Plastic Surgery
91d
Cleared
May 10, 2004
COLLAGEN WOUND DRESSING - ORAL
Collagen Matrix, Inc.
General & Plastic Surgery
83d
Cleared
Mar 17, 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
Collagen Matrix, Inc.
General & Plastic Surgery
14d
Cleared
Feb 27, 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
Collagen Matrix, Inc.
General & Plastic Surgery
28d
Cleared
Sep 29, 2003
DRESSSKIN
Tei Biosciences, Inc.
General & Plastic Surgery
321d
Cleared
May 15, 2003
COLLAGEN TOPICAL WOUND DRESSING
Collagen Matrix, Inc.
General & Plastic Surgery
52d
Cleared
Dec 30, 2002
ACELL UBM HYDRATED WOUND DRESSING
Acell, Inc.
General & Plastic Surgery
137d
Cleared
Dec 19, 2002
ACELL UBM LYOPHILIZED WOUND DRESSING
Acell, Inc.
General & Plastic Surgery
216d
Cleared
Sep 10, 2002
AVAGEN WOUND DRESSING
Integra Lifesciences Corp.
General & Plastic Surgery
71d
Cleared
Aug 14, 2002
BILAYER MATRIX WOUND DRESSING
Integra Lifesciences Corp.
General & Plastic Surgery
75d
Cleared
May 30, 2002
SS MATRIX
Cook Biotech, Inc.
General & Plastic Surgery
85d
Cleared
Apr 18, 2000
MEDTRADE PRODUCTS ALGINATE ISLAND
Medtrade Products , Ltd.
General & Plastic Surgery
64d
Cleared
Mar 22, 2000
HYCURE ORAL / HYCURE ORAL SMART GEL
The Hymed Group Corp.
General & Plastic Surgery
90d
Cleared
Jan 06, 2000
SIS WOUND DRESSING II
Cook Biotech, Inc.
General & Plastic Surgery
45d
Cleared
May 18, 1999
SIGNADRESS DUODERM DRESSING
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
Integra Lifesciences Corp.
General & Plastic Surgery
79d
Cleared
Mar 03, 1999
HA ABSORBENT WOUND DRESSING
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
85d