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 Integra Lifesciences Corp..

191
Total
191
Cleared
155d
Avg days
1979
Since
191 devices
73–96 of 191
Cleared May 25, 2018
SURECELL Gelling Fiber Wound Dressing
K173005
Jiangsu Newvalue Medical Producst Co.,Ltd
General & Plastic Surgery · 240d
Cleared May 11, 2018
Cytal Wound Particulate
K180776
Acell, Inc.
General & Plastic Surgery · 49d
Cleared Mar 16, 2018
XCelliStem Wound Powder
K172593
Stemsys
General & Plastic Surgery · 199d
Cleared Mar 02, 2018
ologen Collagen Matrix
K173223
Aeon Astron Europe B.V.
General & Plastic Surgery · 150d
Cleared Dec 07, 2017
gel-e Bandage
K172010
Gel-E, Inc. (Formerly Remedium Technologies, Inc.)
General & Plastic Surgery · 157d
Cleared Nov 03, 2017
Geistlich Wound Matrix
K171842
Geistlich Pharma AG
General & Plastic Surgery · 136d
Cleared Oct 06, 2017
MicroMatrix
K172399
Acell, Inc.
General & Plastic Surgery · 59d
Cleared Jul 25, 2017
CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
K171645
Strukmyer Medical
General & Plastic Surgery · 50d
Cleared Jun 14, 2017
Endoform Topical Matrix
K171231
Aroa Biosurgery
General & Plastic Surgery · 48d
Cleared Jun 02, 2017
KeraStat(R) Gel
K162759
Keranetics, LLC
General & Plastic Surgery · 245d
Cleared May 10, 2017
ABCcolla Collagen Matrix
K162348
Acro Biomedical Co., Ltd.
General & Plastic Surgery · 261d
Cleared Sep 28, 2016
Flowable Wound Matrix
K160136
Cook Biotech Incorporated
General & Plastic Surgery · 252d
Cleared Jun 23, 2016
Collagen Dental Wound Dressings
K152600
Collagen Matrix, Inc.
General & Plastic Surgery · 286d
Cleared Mar 14, 2016
MicroMatrix
K153754
Acell, Inc.
General & Plastic Surgery · 76d
Cleared Feb 22, 2016
PriMatrix Dermal Repair Scaffold
K153690
Tei Biosciences, Inc.
General & Plastic Surgery · 61d
Cleared Dec 08, 2015
Cytal Wound Matrix
K152721
Acell, Inc.
General & Plastic Surgery · 78d
Cleared Aug 19, 2015
Cook ECM Powder
K152033
Cook Biotech Incorporated
General & Plastic Surgery · 28d
Cleared Jun 26, 2015
XENOMEM WOUND MATRIX
K140820
Viscus Biologics, LLC
General & Plastic Surgery · 451d
Cleared Feb 17, 2015
MEDEOR MATRIX WOUND DRESSING
K141738
Kensey Nash Corporation Dba Dsm Biomedical
General & Plastic Surgery · 235d
Cleared Jan 27, 2015
Wound Matrix TF
K143426
Miromatrix Medical, Inc.
General & Plastic Surgery · 57d
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