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 Stimlabs, LLC.
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
183 total 510(k) submissions under product code KGN since 1979, with 183 receiving FDA clearance (average review time: 154 days).
Submission volume has remained relatively stable over the observed period, with 22 submissions in the last 24 months.
FDA Review Time
FDA review times for KGN submissions have been consistent, averaging 144 days recently vs 156 days historically.
KGN devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →