510(k) K240753

Miro3D Fibers Wound Matrix by Reprise Biomedical, Inc. — Product Code KGN

K240753 is an FDA 510(k) premarket notification submitted by Reprise Biomedical, Inc. for the device "Miro3D Fibers Wound Matrix". The FDA issued a decision of Substantially Equivalent on April 19, 2024. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Reprise Biomedical, Inc. has at least 4 other 510(k) clearances on record.