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 Kerecis Limited.
FDA 510(k) Cleared Wound Dressing With Animal-derived Material(s) Devices (Product Code KGN)
About Product Code KGN - Regulatory Context
510(k) Submission Activity
195 total 510(k) submissions under product code KGN since 1979, with 195 receiving FDA clearance (average review time: 156 days).
Submission volume has increased in recent years - 28 submissions in the last 24 months compared to 21 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - KGN Product Code
FDA review times for KGN submissions have been consistent, averaging 169 days recently vs 154 days historically.
KGN devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →