510(k) K260508

LOBO Vascular Occlusion System by Okami Medical, Inc. — Product Code KRD

K260508 is an FDA 510(k) premarket notification submitted by Okami Medical, Inc. for the device "LOBO Vascular Occlusion System". The FDA issued a decision of Substantially Equivalent on April 10, 2026. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Okami Medical, Inc. has at least 6 other 510(k) clearances on record.