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 Geistlich Pharma AG, Acell, Inc. and Huizhou Foryou Medical Devices Co., Ltd..

13
Total
13
Cleared
186d
Avg days
2021
Since

List of Wound Dressing With Animal-derived Material(s) devices cleared through 510(k)

13 devices
1–13 of 13
Cleared Mar 19, 2026
Derma-Gide
K260532
Geistlich Pharma AG
General & Plastic Surgery · 30d
Cleared Jan 22, 2026
Device 104 Particulate
K251323
Geistlich Pharma AG
General & Plastic Surgery · 268d
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 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 Sep 22, 2023
MicroMatrix® Flex
K230980
Acell, Inc.
General & Plastic Surgery · 170d
Cleared Jun 09, 2023
NovoGen Wound Matrix
K220498
Novabone Products, LLC
General & Plastic Surgery · 472d
Cleared Sep 20, 2022
LUOFUCON Collagen Wound Dressing
K213598
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 309d
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 Oct 08, 2021
INTEGRA Wound Matrix (Macro-Channels)
K210128
Integra LifeSciences Corporation
General & Plastic Surgery · 262d

How to use this database

This page lists all FDA 510(k) submissions for Wound Dressing With Animal-derived Material(s) devices (product code KGN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →