510(k) K223257

Miro3D Wound Matrix by Reprise Biomedical — Product Code KGN

K223257 is an FDA 510(k) premarket notification submitted by Reprise Biomedical for the device "Miro3D Wound Matrix". The FDA issued a decision of Substantially Equivalent on November 21, 2022. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Reprise Biomedical has at least 4 other 510(k) clearances on record.