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 Innocoll Pharmaceuticals.

195
Total
195
Cleared
156d
Avg days
1979
Since
195 devices
97–120 of 195
Cleared Jan 26, 2015
KA01 Chitosan Wound Dressing
K143124
Foshan United Medical Technologies, Ltd.
General & Plastic Surgery · 87d
Cleared Jan 08, 2015
Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
K142712
Novabone Products, LLC
General & Plastic Surgery · 108d
Cleared Sep 12, 2014
ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
K140367
Harbor Medtech, Inc.
General & Plastic Surgery · 210d
Cleared Aug 07, 2014
PREMVIA
K134037
Biotime, Inc.
General & Plastic Surgery · 219d
Cleared Jul 22, 2014
BIO-CONNEKT WOUND MATRIX
K140456
MLM Biologics, Inc.
General & Plastic Surgery · 148d
Cleared Jun 19, 2014
MIROMATRIX WOUND MATRIX
K140510
Miromatrix Medical, Inc.
General & Plastic Surgery · 111d
Cleared May 01, 2014
COLLACARE DENTAL
K133290
Innocoll Pharmaceuticals
General & Plastic Surgery · 188d
Cleared Oct 23, 2013
MARIGEN WOUND DRESSING
K132343
Kerecis Limited
General & Plastic Surgery · 85d
Cleared Aug 16, 2013
COVAGEN
K123756
Covalon Technologies, Ltd.
General & Plastic Surgery · 252d
Cleared Aug 05, 2013
PRIMATRIX DERMAL REPAIR SCAFFOLD
K131286
Tei Biosciences, Inc.
General & Plastic Surgery · 91d
Cleared Apr 21, 2013
FIBRILLAR COLLAGEN WOUND DRESSING
K120250
Collafirm, LLC
General & Plastic Surgery · 450d
Cleared Apr 05, 2013
SENTREX BIOSPONGE MPD
K123961
Bionova Medical, Inc.
General & Plastic Surgery · 100d
Cleared Feb 26, 2013
BRIDGE EXTRACELLULAR COLLEGEN MATRIX
K122502
Harbor Medtech, Inc.
General & Plastic Surgery · 194d
Cleared Nov 01, 2012
COLLAGEN DENTAL WOUND DRESSINGS
K122115
Collagen Matrix, Inc.
General & Plastic Surgery · 107d
Cleared Oct 26, 2012
SKINTEMP II
K122325
Human Biosciences, Inc.
General & Plastic Surgery · 86d
Cleared Jun 21, 2012
PROCOLL
K120339
Innocoll Pharmaceuticals
General & Plastic Surgery · 139d
Cleared Jun 05, 2012
HEALEX BIOSPONGE WOUND DRESSING
K112191
Bionova Medical, Inc.
General & Plastic Surgery · 312d
Cleared Jun 01, 2012
COLLAGEN WOUND DRESSING
K112580
Dalim Tissen Co., Ltd.
General & Plastic Surgery · 269d
Cleared Mar 23, 2012
PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX
K113866
Brennen Medical, LLC
General & Plastic Surgery · 84d
Cleared Feb 10, 2012
MESO WOUND MATRIX
K112888
Kensey Nash Corporation
General & Plastic Surgery · 133d
Cleared Feb 09, 2012
INTEGRA WOUND MATRIX (THIN)
K113104
Integra LifeSciences Corporation
General & Plastic Surgery · 112d
Cleared Oct 03, 2011
EXCELLAGEN
K110318
Tissue Repair Company
General & Plastic Surgery · 243d
Cleared Sep 14, 2011
COLLAGEN POWDER
K103648
Innocoll Pharmaceuticals, Ltd.
General & Plastic Surgery · 274d
Cleared Sep 07, 2011
UNITE BIOMATRIX
K112399
Synovis Orthopedic & Woundcare
General & Plastic Surgery · 19d