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 Innocoll Pharmaceuticals.
195
Total
195
Cleared
156d
Avg days
1979
Since
195 devices
Cleared
Mar 02, 2007
MODIFICATION TO COLLAWOUND DRESSING
Collamatrix Co., Inc.
General & Plastic Surgery
32d
Cleared
Oct 02, 2006
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
Innocoll Pharmaceuticals
General & Plastic Surgery
103d
Cleared
Sep 21, 2006
DERMADAPT WOUND DRESSING
Pegasus Biologics, Inc.
General & Plastic Surgery
113d
Cleared
Jul 19, 2006
OASIS WOUND MATRIX
Cook Biotech, Inc.
General & Plastic Surgery
30d
Cleared
Jul 05, 2006
COLLAWOUND DRESSING
Collamatrix Co., Inc.
General & Plastic Surgery
36d
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
Aug 12, 2004
HEALICOLL
Encoll Corp.
General & Plastic Surgery
185d
Cleared
Aug 09, 2004
STIMULEN COLLAGEN
Southwest Technologies, Inc.
General & Plastic Surgery
517d
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
Feb 14, 2002
PROMOGRAN MATRIX WOUND DRESSING
Johnson & Johnson Medical, Ltd.
General & Plastic Surgery
59d
Cleared
Oct 24, 2001
COLLATEK POWDER
Biocore Medical Technologies, Inc.
General & Plastic Surgery
48d
Cleared
Jun 13, 2001
FORTADERM WOUND DRESSING
Organogenesis, Inc.
General & Plastic Surgery
70d