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 Geistlich Pharma AG.
187
Total
187
Cleared
154d
Avg days
1979
Since
187 devices
Cleared
Jul 11, 2024
MicroMatrix® UBM Particulate
Acell, Inc.
General & Plastic Surgery
28d
Cleared
Jul 11, 2024
Cytal® Wound Matrix
Acell, Inc.
General & Plastic Surgery
27d
Cleared
Apr 25, 2024
LUOFUCON® Collagen Particles (Collagen Wound Dressing)
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
226d
Cleared
Apr 19, 2024
ReyaGel (RG03 - MTP gel 3mL)
Fettech
General & Plastic Surgery
269d
Cleared
Apr 19, 2024
Miro3D Fibers Wound Matrix
Reprise Biomedical, Inc.
General & Plastic Surgery
30d
Cleared
Mar 01, 2024
MiroDry Wound Matrix
Reprise Biomedical, Inc.
General & Plastic Surgery
30d
Cleared
Feb 02, 2024
Corplex P / Theracor P / Allacor P
Stimlabs, LLC
General & Plastic Surgery
270d
Cleared
Dec 13, 2023
MiroTract Wound Matrix
Reprise Biomedical, Inc.
General & Plastic Surgery
194d
Cleared
Dec 01, 2023
Comatryx OTC
Strukmyer Medical, LLC
General & Plastic Surgery
84d
Cleared
Nov 13, 2023
Foundation Dermal Regeneration Scaffold (DRS) Solo
Bionova Medical, Inc.
General & Plastic Surgery
136d
Cleared
Oct 12, 2023
Collagen Wound Dressing
Winner Medical Co., Ltd.
General & Plastic Surgery
171d
Cleared
Oct 11, 2023
SurgiAid® Collagen Wound Dressing
Maxigen Biotech, Inc.
General & Plastic Surgery
373d
Cleared
Sep 22, 2023
MicroMatrix® Flex
Acell, Inc.
General & Plastic Surgery
170d
Cleared
Aug 24, 2023
Maxiocel Chitosan Wound Dressing
Advamedica, Inc.
General & Plastic Surgery
723d
Cleared
Jun 09, 2023
NovoGen Wound Matrix
Novabone Products, LLC
General & Plastic Surgery
472d
Cleared
May 02, 2023
FortiShield (Biosynthetic Wound Matrix)
Organogenesis, Inc.
General & Plastic Surgery
624d
Cleared
Nov 21, 2022
Miro3D Wound Matrix
Reprise Biomedical
General & Plastic Surgery
31d
Cleared
Sep 29, 2022
InnovaBurn
Triad Life Sciences, Inc.
General & Plastic Surgery
309d
Cleared
Sep 28, 2022
InnovaMatrix PD
Triad Life Sciences, Inc.
General & Plastic Surgery
464d
Cleared
Sep 20, 2022
LUOFUCON Collagen Wound Dressing
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
309d
Cleared
Aug 18, 2022
Miro3D Wound Matrix
Reprise Biomedical, Inc.
General & Plastic Surgery
85d
Cleared
Aug 11, 2022
Foundation Dermal Regeneration Scaffold (DRS) Solo
Bionova Medical, Inc.
General & Plastic Surgery
499d
Cleared
Jul 14, 2022
PELNAC Meshed Bilayer Wound Matrix
Gunze Limited
General & Plastic Surgery
255d
Cleared
Jul 01, 2022
PuraPly Micronized Wound Matrix (PuraPly MZ)
Organogenesis, Inc.
General & Plastic Surgery
148d