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 Collagen Matrix, Inc., Acell, Inc. and Reprise Biomedical, Inc..

190
Total
190
Cleared
154d
Avg days
1979
Since
190 devices
73–96 of 190
Cleared Jun 23, 2016
Collagen Dental Wound Dressings
K152600
Collagen Matrix, Inc.
General & Plastic Surgery · 286d
Cleared Nov 01, 2012
COLLAGEN DENTAL WOUND DRESSINGS
K122115
Collagen Matrix, Inc.
General & Plastic Surgery · 107d
Cleared Feb 09, 2012
INTEGRA WOUND MATRIX (THIN)
K113104
Integra LifeSciences Corporation
General & Plastic Surgery · 112d
Cleared Jul 30, 2009
ATLAS WOUND MATRIX
K090954
Wrightmedicaltechnologyinc
General & Plastic Surgery · 115d
Cleared Jun 19, 2006
MEDLINE COLLAGEN WOUND DRESSING
K060456
Medline Industries, Inc.
General & Plastic Surgery · 117d
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 May 15, 2003
COLLAGEN TOPICAL WOUND DRESSING
K030921
Collagen Matrix, Inc.
General & Plastic Surgery · 52d
Cleared May 18, 1999
SIGNADRESS DUODERM DRESSING
K990964
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 56d
Cleared Mar 03, 1999
HA ABSORBENT WOUND DRESSING
K984388
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 85d
Cleared Aug 20, 1998
FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
K982597
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 27d
Cleared Apr 23, 1997
KENDALL HYDROPHILIC POWDER WOUND DRESSING
K970266
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 90d