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 Kerecis Limited.
195
Total
195
Cleared
156d
Avg days
1979
Since
195 devices
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
May 20, 2011
CORELEADER COLLA-PAD MODEL CS 03030
Coreleader Biotech Co., Ltd.
General & Plastic Surgery
228d
Cleared
Feb 02, 2011
SURGIAID
Maxigen Biotech, Inc.
General & Plastic Surgery
303d
Cleared
Oct 28, 2010
COLLEXA
Innocoll Pharmaceuticals
General & Plastic Surgery
241d
Cleared
Jun 23, 2010
ENDOFORM DENTAL TEMPLATE
Mesynthes, Ltd.
General & Plastic Surgery
20d
Cleared
Feb 16, 2010
COLLAGEN SPONGE
Innocoll Pharmaceuticals
General & Plastic Surgery
158d
Cleared
Jan 21, 2010
ENDOFORM DERMAL TEMPLATE
Mesynthes, Ltd.
General & Plastic Surgery
191d
Cleared
Oct 28, 2009
ACELL MATRISTEM WOUND SHEET
Acell, Inc.
General & Plastic Surgery
35d
Cleared
Oct 22, 2009
THERAFORM BILAYER
Sewon Cellontech Co., Ltd.
General & Plastic Surgery
210d
Cleared
Aug 26, 2009
COLLASORB COLLAGEN WOUND DRESSING
Hartmann-Conco, Inc.
General & Plastic Surgery
112d
Cleared
Jul 30, 2009
THERAFORM STANDARD/SHEET
Sewon Cellontech Co., Ltd.
General & Plastic Surgery
127d
Cleared
Jul 30, 2009
ATLAS WOUND MATRIX
Wrightmedicaltechnologyinc
General & Plastic Surgery
115d
Cleared
Jun 25, 2009
COLLAWOUND WOUND DRESSING
Collamatrix Co., Inc.
General & Plastic Surgery
86d
Cleared
May 14, 2009
AONGEN COLLAGEN MATRIX
Aeon Astron Europe B.V.
General & Plastic Surgery
412d
Cleared
Feb 06, 2009
AWBAT-S, AWBAT-D, AWBAT-M
Aubrey, Inc.
General & Plastic Surgery
130d
Cleared
Dec 12, 2008
PRIMATRIX DERMAL REPAIR SCAFFOLD
Tei Biosciences, Inc.
General & Plastic Surgery
22d
Cleared
Dec 04, 2008
INTEGRA MESHED BILAYER WOUND MATRIX
Integra Lifesciences Corp.
General & Plastic Surgery
176d
Cleared
Oct 30, 2008
HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL
Applied Nutritionals
General & Plastic Surgery
134d
Cleared
Oct 08, 2008
LTM WOUND DRESSING
Lifecell Corp.
General & Plastic Surgery
75d
Cleared
Sep 30, 2008
COLLIEVA
Innocoll Pharmaceuticals
General & Plastic Surgery
99d
Cleared
Mar 14, 2008
NOCC HYDROPHILIC WOUND DRESSING
Kytogenics, Inc.
General & Plastic Surgery
71d
Cleared
Oct 10, 2007
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
Integra Lifesciences Corp.
General & Plastic Surgery
70d
Cleared
Jun 20, 2007
UNITE BIOMATRIX
Pegasus Biologics, Inc.
General & Plastic Surgery
28d