510(k) K253040

Aevumed FASE Suture Anchor by Aevumed, Inc. — Product Code MBI

K253040 is an FDA 510(k) premarket notification submitted by Aevumed, Inc. for the device "Aevumed FASE Suture Anchor". The FDA issued a decision of Substantially Equivalent on October 21, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Aevumed, Inc. has at least 7 other 510(k) clearances on record.