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 Innocoll Pharmaceuticals.

195
Total
195
Cleared
156d
Avg days
1979
Since
195 devices
25–48 of 195
Cleared Jun 20, 2025
CollOvine™ Wound Dressing
K242985
Ovigenex, LLC
General & Plastic Surgery · 267d
Cleared Jan 06, 2025
DermiSphere Dermal Template
K241904
Fesariustherapeutics, Inc.
General & Plastic Surgery · 189d
Cleared Dec 19, 2024
Bovine Dermis Collagen Dermal Matrix
K243071
Collagen Matrix, Inc.
General & Plastic Surgery · 83d
Cleared Dec 17, 2024
BIOBRANE Temporary Wound Dressing
K242146
Smith & Nephew Medical Limited
General & Plastic Surgery · 147d
Cleared Oct 18, 2024
ABCcolla® Collagen ADM Scaffold
K233378
Acro Biomedical Co., Ltd.
General & Plastic Surgery · 382d
Cleared Oct 18, 2024
Corplex P/ Theracor P/ Allacor P
K242828
Stimlabs, LLC
General & Plastic Surgery · 29d
Cleared Aug 21, 2024
Kerecis Parvus (50207)
K241080
Kerecis Limited
General & Plastic Surgery · 124d
Cleared Jul 26, 2024
InnovaMatrix®FD
K241866
Convatec Triad Life Sciences, LLC
General & Plastic Surgery · 29d
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