510(k) K251323

Device 104 Particulate by Geistlich Pharma AG — Product Code KGN

K251323 is an FDA 510(k) premarket notification submitted by Geistlich Pharma AG for the device "Device 104 Particulate". The FDA issued a decision of Substantially Equivalent on January 22, 2026. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Geistlich Pharma AG has at least 10 other 510(k) clearances on record.