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 Kerecis Limited.

195
Total
195
Cleared
156d
Avg days
1979
Since
195 devices
121–144 of 195
Cleared Aug 29, 2011
MATRISTEM WOUND MATRIX
K112409
Acell, Inc.
General & Plastic Surgery · 7d
Cleared Aug 09, 2011
COLLACARE DENTAL
K110388
Innocoll Pharmaceuticals, Ltd.
General & Plastic Surgery · 180d
Cleared May 20, 2011
CORELEADER COLLA-PAD MODEL CS 03030
K102946
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 228d
Cleared Feb 02, 2011
SURGIAID
K100927
Maxigen Biotech, Inc.
General & Plastic Surgery · 303d
Cleared Oct 28, 2010
COLLEXA
K100574
Innocoll Pharmaceuticals
General & Plastic Surgery · 241d
Cleared Jun 23, 2010
ENDOFORM DENTAL TEMPLATE
K101546
Mesynthes, Ltd.
General & Plastic Surgery · 20d
Cleared Feb 16, 2010
COLLAGEN SPONGE
K092805
Innocoll Pharmaceuticals
General & Plastic Surgery · 158d
Cleared Jan 21, 2010
ENDOFORM DERMAL TEMPLATE
K092096
Mesynthes, Ltd.
General & Plastic Surgery · 191d
Cleared Oct 28, 2009
ACELL MATRISTEM WOUND SHEET
K092926
Acell, Inc.
General & Plastic Surgery · 35d
Cleared Oct 22, 2009
THERAFORM BILAYER
K090823
Sewon Cellontech Co., Ltd.
General & Plastic Surgery · 210d
Cleared Aug 26, 2009
COLLASORB COLLAGEN WOUND DRESSING
K091338
Hartmann-Conco, Inc.
General & Plastic Surgery · 112d
Cleared Jul 30, 2009
THERAFORM STANDARD/SHEET
K090812
Sewon Cellontech Co., Ltd.
General & Plastic Surgery · 127d
Cleared Jul 30, 2009
ATLAS WOUND MATRIX
K090954
Wrightmedicaltechnologyinc
General & Plastic Surgery · 115d
Cleared Jun 25, 2009
COLLAWOUND WOUND DRESSING
K090894
Collamatrix Co., Inc.
General & Plastic Surgery · 86d
Cleared May 14, 2009
AONGEN COLLAGEN MATRIX
K080868
Aeon Astron Europe B.V.
General & Plastic Surgery · 412d
Cleared Feb 06, 2009
AWBAT-S, AWBAT-D, AWBAT-M
K082869
Aubrey, Inc.
General & Plastic Surgery · 130d
Cleared Dec 12, 2008
PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440
Tei Biosciences, Inc.
General & Plastic Surgery · 22d
Cleared Dec 04, 2008
INTEGRA MESHED BILAYER WOUND MATRIX
K081635
Integra Lifesciences Corp.
General & Plastic Surgery · 176d
Cleared Oct 30, 2008
HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL
K081724
Applied Nutritionals
General & Plastic Surgery · 134d
Cleared Oct 08, 2008
LTM WOUND DRESSING
K082103
Lifecell Corp.
General & Plastic Surgery · 75d
Cleared Sep 30, 2008
COLLIEVA
K081782
Innocoll Pharmaceuticals
General & Plastic Surgery · 99d
Cleared Mar 14, 2008
NOCC HYDROPHILIC WOUND DRESSING
K080010
Kytogenics, Inc.
General & Plastic Surgery · 71d
Cleared Oct 10, 2007
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113
Integra Lifesciences Corp.
General & Plastic Surgery · 70d
Cleared Jun 20, 2007
UNITE BIOMATRIX
K071425
Pegasus Biologics, Inc.
General & Plastic Surgery · 28d