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., Triad Life Sciences, Inc. and Reprise Biomedical, Inc..
187
Total
187
Cleared
154d
Avg days
1979
Since
187 devices
Cleared
Jun 29, 2022
Kerecis Silicone
Kerecis Limited
General & Plastic Surgery
272d
Cleared
May 31, 2022
Fibrillar Collagen Wound Dressing
Collagen Matrix, Inc.
General & Plastic Surgery
236d
Cleared
Apr 28, 2022
Geistlich Wound Matrix PLUS
Geistlich Pharma AG
General & Plastic Surgery
164d
Cleared
Feb 09, 2022
PELNAC Wound Matrix
Gunze Limited
General & Plastic Surgery
91d
Cleared
Dec 15, 2021
Cellusheet, Cellufil
Human Biosciences, Inc.
General & Plastic Surgery
82d
Cleared
Oct 08, 2021
INTEGRA Wound Matrix (Macro-Channels)
Integra LifeSciences Corporation
General & Plastic Surgery
262d
Cleared
Oct 07, 2021
NeoMatriX Wound Matrix
Nextgen Biologics, Inc.
General & Plastic Surgery
276d
Cleared
Apr 21, 2021
InnovaMatrix FS
Triad Life Sciences, Inc.
General & Plastic Surgery
54d
Cleared
Mar 31, 2021
Myriad Particles
Aroa Biosurgery , Ltd.
General & Plastic Surgery
397d
Cleared
Jan 07, 2021
MatriDerm
Medskin Solutions Dr. Suwelack AG
General & Plastic Surgery
210d
Cleared
Oct 21, 2020
InnovaMatrix
Triad Life Sciences, Inc.
General & Plastic Surgery
306d
Cleared
Jul 29, 2020
Symphony
Aroa Biosurgery , Ltd.
General & Plastic Surgery
161d
Cleared
Jul 16, 2020
KeraStat Cream
Keranetics
General & Plastic Surgery
317d
Cleared
Apr 29, 2020
PELNAC Bilayer Wound Matrix
Gunze Limited
General & Plastic Surgery
279d
Cleared
Feb 28, 2020
scaffolene CL100 Bioresorbable Collagen Matrix
Freudenberg Technology Innovation SE & Co. KG
General & Plastic Surgery
183d
Cleared
Oct 25, 2019
Cytal Wound Matrix 3-Layer
Acell, Inc.
General & Plastic Surgery
28d
Cleared
Jul 10, 2019
MariGen Wound Extra
Kerecis Limited
General & Plastic Surgery
128d
Cleared
Jan 17, 2019
ProgenaMatrix
Cell Constructs I, LLC
General & Plastic Surgery
174d
Cleared
Nov 08, 2018
Geistlich Derma-Gide
Geistlich Pharma AG
General & Plastic Surgery
30d
Cleared
Oct 11, 2018
NeoMatriX Wound Matrix
Nextgen Biologics, Inc.
General & Plastic Surgery
146d
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