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 Innocoll Pharmaceuticals.

195
Total
195
Cleared
156d
Avg days
1979
Since
195 devices
145–168 of 195
Cleared Mar 02, 2007
MODIFICATION TO COLLAWOUND DRESSING
K070269
Collamatrix Co., Inc.
General & Plastic Surgery · 32d
Cleared Oct 02, 2006
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
K061746
Innocoll Pharmaceuticals
General & Plastic Surgery · 103d
Cleared Sep 21, 2006
DERMADAPT WOUND DRESSING
K061494
Pegasus Biologics, Inc.
General & Plastic Surgery · 113d
Cleared Jul 19, 2006
OASIS WOUND MATRIX
K061711
Cook Biotech, Inc.
General & Plastic Surgery · 30d
Cleared Jul 05, 2006
COLLAWOUND DRESSING
K061474
Collamatrix Co., Inc.
General & Plastic Surgery · 36d
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 Aug 12, 2004
HEALICOLL
K040314
Encoll Corp.
General & Plastic Surgery · 185d
Cleared Aug 09, 2004
STIMULEN COLLAGEN
K030774
Southwest Technologies, Inc.
General & Plastic Surgery · 517d
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 Feb 14, 2002
PROMOGRAN MATRIX WOUND DRESSING
K014129
Johnson & Johnson Medical, Ltd.
General & Plastic Surgery · 59d
Cleared Oct 24, 2001
COLLATEK POWDER
K012990
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 48d
Cleared Jun 13, 2001
FORTADERM WOUND DRESSING
K011026
Organogenesis, Inc.
General & Plastic Surgery · 70d