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., Triad Life Sciences, Inc. and Geistlich Pharma AG.

187
Total
187
Cleared
154d
Avg days
1979
Since
187 devices
25–48 of 187
Cleared Jul 11, 2024
MicroMatrix® UBM Particulate
K241706
Acell, Inc.
General & Plastic Surgery · 28d
Cleared Jul 11, 2024
Cytal® Wound Matrix
K241724
Acell, Inc.
General & Plastic Surgery · 27d
Cleared Apr 25, 2024
LUOFUCON® Collagen Particles (Collagen Wound Dressing)
K232796
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 226d
Cleared Apr 19, 2024
ReyaGel (RG03 - MTP gel 3mL)
K232204
Fettech
General & Plastic Surgery · 269d
Cleared Apr 19, 2024
Miro3D Fibers Wound Matrix
K240753
Reprise Biomedical, Inc.
General & Plastic Surgery · 30d
Cleared Mar 01, 2024
MiroDry Wound Matrix
K240277
Reprise Biomedical, Inc.
General & Plastic Surgery · 30d
Cleared Feb 02, 2024
Corplex P / Theracor P / Allacor P
K231325
Stimlabs, LLC
General & Plastic Surgery · 270d
Cleared Dec 13, 2023
MiroTract Wound Matrix
K231614
Reprise Biomedical, Inc.
General & Plastic Surgery · 194d
Cleared Dec 01, 2023
Comatryx OTC
K232758
Strukmyer Medical, LLC
General & Plastic Surgery · 84d
Cleared Nov 13, 2023
Foundation Dermal Regeneration Scaffold (DRS) Solo
K231937
Bionova Medical, Inc.
General & Plastic Surgery · 136d
Cleared Oct 12, 2023
Collagen Wound Dressing
K231152
Winner Medical Co., Ltd.
General & Plastic Surgery · 171d
Cleared Oct 11, 2023
SurgiAid® Collagen Wound Dressing
K223126
Maxigen Biotech, Inc.
General & Plastic Surgery · 373d
Cleared Sep 22, 2023
MicroMatrix® Flex
K230980
Acell, Inc.
General & Plastic Surgery · 170d
Cleared Aug 24, 2023
Maxiocel Chitosan Wound Dressing
K212766
Advamedica, Inc.
General & Plastic Surgery · 723d
Cleared Jun 09, 2023
NovoGen Wound Matrix
K220498
Novabone Products, LLC
General & Plastic Surgery · 472d
Cleared May 02, 2023
FortiShield (Biosynthetic Wound Matrix)
K212579
Organogenesis, Inc.
General & Plastic Surgery · 624d
Cleared Nov 21, 2022
Miro3D Wound Matrix
K223257
Reprise Biomedical
General & Plastic Surgery · 31d
Cleared Sep 29, 2022
InnovaBurn
K213716
Triad Life Sciences, Inc.
General & Plastic Surgery · 309d
Cleared Sep 28, 2022
InnovaMatrix PD
K211902
Triad Life Sciences, Inc.
General & Plastic Surgery · 464d
Cleared Sep 20, 2022
LUOFUCON Collagen Wound Dressing
K213598
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 309d
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