510(k) K250329

GeniPhys Collymer Self-Assembling Scaffold by Geniphys, Inc. — Product Code KGN

K250329 is an FDA 510(k) premarket notification submitted by Geniphys, Inc. for the device "GeniPhys Collymer Self-Assembling Scaffold". The FDA issued a decision of Substantially Equivalent on June 25, 2025. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device.