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
Jul 22, 2014
BIO-CONNEKT WOUND MATRIX
MLM Biologics, Inc.
General & Plastic Surgery
148d
Cleared
Jun 19, 2014
MIROMATRIX WOUND MATRIX
Miromatrix Medical, Inc.
General & Plastic Surgery
111d
Cleared
May 01, 2014
COLLACARE DENTAL
Innocoll Pharmaceuticals
General & Plastic Surgery
188d
Cleared
Oct 23, 2013
MARIGEN WOUND DRESSING
Kerecis Limited
General & Plastic Surgery
85d
Cleared
Aug 16, 2013
COVAGEN
Covalon Technologies, Ltd.
General & Plastic Surgery
252d
Cleared
Aug 05, 2013
PRIMATRIX DERMAL REPAIR SCAFFOLD
Tei Biosciences, Inc.
General & Plastic Surgery
91d
Cleared
Apr 21, 2013
FIBRILLAR COLLAGEN WOUND DRESSING
Collafirm, LLC
General & Plastic Surgery
450d
Cleared
Apr 05, 2013
SENTREX BIOSPONGE MPD
Bionova Medical, Inc.
General & Plastic Surgery
100d
Cleared
Feb 26, 2013
BRIDGE EXTRACELLULAR COLLEGEN MATRIX
Harbor Medtech, Inc.
General & Plastic Surgery
194d
Cleared
Nov 01, 2012
COLLAGEN DENTAL WOUND DRESSINGS
Collagen Matrix, Inc.
General & Plastic Surgery
107d
Cleared
Oct 26, 2012
SKINTEMP II
Human Biosciences, Inc.
General & Plastic Surgery
86d
Cleared
Jun 21, 2012
PROCOLL
Innocoll Pharmaceuticals
General & Plastic Surgery
139d
Cleared
Jun 05, 2012
HEALEX BIOSPONGE WOUND DRESSING
Bionova Medical, Inc.
General & Plastic Surgery
312d
Cleared
Jun 01, 2012
COLLAGEN WOUND DRESSING
Dalim Tissen Co., Ltd.
General & Plastic Surgery
269d
Cleared
Mar 23, 2012
PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX
Brennen Medical, LLC
General & Plastic Surgery
84d
Cleared
Feb 10, 2012
MESO WOUND MATRIX
Kensey Nash Corporation
General & Plastic Surgery
133d
Cleared
Feb 09, 2012
INTEGRA WOUND MATRIX (THIN)
Integra LifeSciences Corporation
General & Plastic Surgery
112d
Cleared
Oct 03, 2011
EXCELLAGEN
Tissue Repair Company
General & Plastic Surgery
243d
Cleared
Sep 14, 2011
COLLAGEN POWDER
Innocoll Pharmaceuticals, Ltd.
General & Plastic Surgery
274d
Cleared
Sep 07, 2011
UNITE BIOMATRIX
Synovis Orthopedic & Woundcare
General & Plastic Surgery
19d
Cleared
Aug 29, 2011
MATRISTEM WOUND MATRIX
Acell, Inc.
General & Plastic Surgery
7d
Cleared
Aug 09, 2011
COLLACARE DENTAL
Innocoll Pharmaceuticals, Ltd.
General & Plastic Surgery
180d
Cleared
Oct 28, 2009
ACELL MATRISTEM WOUND SHEET
Acell, Inc.
General & Plastic Surgery
35d
Cleared
Jul 30, 2009
ATLAS WOUND MATRIX
Wrightmedicaltechnologyinc
General & Plastic Surgery
115d