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
49–72 of 191
Cleared Aug 18, 2022
Miro3D Wound Matrix
K221520
Reprise Biomedical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 11, 2022
Foundation Dermal Regeneration Scaffold (DRS) Solo
K210949
Bionova Medical, Inc.
General & Plastic Surgery · 499d
Cleared Jul 14, 2022
PELNAC Meshed Bilayer Wound Matrix
K213498
Gunze Limited
General & Plastic Surgery · 255d
Cleared Jul 01, 2022
PuraPly Micronized Wound Matrix (PuraPly MZ)
K220317
Organogenesis, Inc.
General & Plastic Surgery · 148d
Cleared Jun 29, 2022
Kerecis Silicone
K213231
Kerecis Limited
General & Plastic Surgery · 272d
Cleared May 31, 2022
Fibrillar Collagen Wound Dressing
K213341
Collagen Matrix, Inc.
General & Plastic Surgery · 236d
Cleared Apr 28, 2022
Geistlich Wound Matrix PLUS
K213607
Geistlich Pharma AG
General & Plastic Surgery · 164d
Cleared Feb 09, 2022
PELNAC Wound Matrix
K213573
Gunze Limited
General & Plastic Surgery · 91d
Cleared Dec 15, 2021
Cellusheet, Cellufil
K213092
Human Biosciences, Inc.
General & Plastic Surgery · 82d
Cleared Oct 08, 2021
INTEGRA Wound Matrix (Macro-Channels)
K210128
Integra LifeSciences Corporation
General & Plastic Surgery · 262d
Cleared Oct 07, 2021
NeoMatriX Wound Matrix
K210024
Nextgen Biologics, Inc.
General & Plastic Surgery · 276d
Cleared Apr 21, 2021
InnovaMatrix FS
K210580
Triad Life Sciences, Inc.
General & Plastic Surgery · 54d
Cleared Mar 31, 2021
Myriad Particles
K200502
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 397d
Cleared Jan 07, 2021
MatriDerm
K201577
Medskin Solutions Dr. Suwelack AG
General & Plastic Surgery · 210d
Cleared Oct 21, 2020
InnovaMatrix
K193552
Triad Life Sciences, Inc.
General & Plastic Surgery · 306d
Cleared Jul 29, 2020
Symphony
K200413
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 161d
Cleared Jul 16, 2020
KeraStat Cream
K192386
Keranetics
General & Plastic Surgery · 317d
Cleared Apr 29, 2020
PELNAC Bilayer Wound Matrix
K191992
Gunze Limited
General & Plastic Surgery · 279d
Cleared Feb 28, 2020
scaffolene CL100 Bioresorbable Collagen Matrix
K192346
Freudenberg Technology Innovation SE & Co. KG
General & Plastic Surgery · 183d
Cleared Oct 25, 2019
Cytal Wound Matrix 3-Layer
K192725
Acell, Inc.
General & Plastic Surgery · 28d
Cleared Jul 10, 2019
MariGen Wound Extra
K190528
Kerecis Limited
General & Plastic Surgery · 128d
Cleared Jan 17, 2019
ProgenaMatrix
K182010
Cell Constructs I, LLC
General & Plastic Surgery · 174d
Cleared Nov 08, 2018
Geistlich Derma-Gide
K182838
Geistlich Pharma AG
General & Plastic Surgery · 30d
Cleared Oct 11, 2018
NeoMatriX Wound Matrix
K181330
Nextgen Biologics, Inc.
General & Plastic Surgery · 146d