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 Integra Lifesciences Corp..
191
Total
191
Cleared
155d
Avg days
1979
Since
191 devices
Cleared
Aug 20, 1998
FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
Johnson & Johnson Medical, Inc.
General & Plastic Surgery
27d
Cleared
Apr 30, 1998
SIS WOUND DRESSING
Cook Biotech, Inc.
General & Plastic Surgery
248d
Cleared
Apr 23, 1997
KENDALL HYDROPHILIC POWDER WOUND DRESSING
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery
90d
Cleared
Dec 18, 1996
REPLIDERM WOUND DRESSING
Orphan Medical, Inc.
General & Plastic Surgery
121d
Cleared
Jan 17, 1996
HYCURE
The Hymed Group Corp.
General & Plastic Surgery
47d
Cleared
Jun 28, 1995
MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING
Brennen Medical, Inc.
General & Plastic Surgery
175d
Cleared
Apr 13, 1995
MESH MATRIX WOUND DRESSING
Brennen Medical, Inc.
General & Plastic Surgery
79d
Cleared
Jul 11, 1994
E-Z DERM BIOSYNTHETIC WOUND DRESSING
Brennen Medical, Inc.
General & Plastic Surgery
258d