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
May 25, 2018
SURECELL Gelling Fiber Wound Dressing
Jiangsu Newvalue Medical Producst Co.,Ltd
General & Plastic Surgery
240d
Cleared
May 11, 2018
Cytal Wound Particulate
Acell, Inc.
General & Plastic Surgery
49d
Cleared
Mar 16, 2018
XCelliStem Wound Powder
Stemsys
General & Plastic Surgery
199d
Cleared
Mar 02, 2018
ologen Collagen Matrix
Aeon Astron Europe B.V.
General & Plastic Surgery
150d
Cleared
Dec 07, 2017
gel-e Bandage
Gel-E, Inc. (Formerly Remedium Technologies, Inc.)
General & Plastic Surgery
157d
Cleared
Nov 03, 2017
Geistlich Wound Matrix
Geistlich Pharma AG
General & Plastic Surgery
136d
Cleared
Oct 06, 2017
MicroMatrix
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
Strukmyer Medical
General & Plastic Surgery
50d
Cleared
Jun 14, 2017
Endoform Topical Matrix
Aroa Biosurgery
General & Plastic Surgery
48d
Cleared
Jun 02, 2017
KeraStat(R) Gel
Keranetics, LLC
General & Plastic Surgery
245d
Cleared
May 10, 2017
ABCcolla Collagen Matrix
Acro Biomedical Co., Ltd.
General & Plastic Surgery
261d
Cleared
Sep 28, 2016
Flowable Wound Matrix
Cook Biotech Incorporated
General & Plastic Surgery
252d
Cleared
Jun 23, 2016
Collagen Dental Wound Dressings
Collagen Matrix, Inc.
General & Plastic Surgery
286d
Cleared
Mar 14, 2016
MicroMatrix
Acell, Inc.
General & Plastic Surgery
76d
Cleared
Feb 22, 2016
PriMatrix Dermal Repair Scaffold
Tei Biosciences, Inc.
General & Plastic Surgery
61d
Cleared
Dec 08, 2015
Cytal Wound Matrix
Acell, Inc.
General & Plastic Surgery
78d
Cleared
Aug 19, 2015
Cook ECM Powder
Cook Biotech Incorporated
General & Plastic Surgery
28d
Cleared
Jun 26, 2015
XENOMEM WOUND MATRIX
Viscus Biologics, LLC
General & Plastic Surgery
451d
Cleared
Feb 17, 2015
MEDEOR MATRIX WOUND DRESSING
Kensey Nash Corporation Dba Dsm Biomedical
General & Plastic Surgery
235d
Cleared
Jan 27, 2015
Wound Matrix TF
Miromatrix Medical, Inc.
General & Plastic Surgery
57d
Cleared
Jan 26, 2015
KA01 Chitosan Wound Dressing
Foshan United Medical Technologies, Ltd.
General & Plastic Surgery
87d
Cleared
Jan 08, 2015
Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
Novabone Products, LLC
General & Plastic Surgery
108d
Cleared
Sep 12, 2014
ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
Harbor Medtech, Inc.
General & Plastic Surgery
210d
Cleared
Aug 07, 2014
PREMVIA
Biotime, Inc.
General & Plastic Surgery
219d