510(k) K232684

Surgify Halo by Surgify Medical OY — Product Code HBE

K232684 is an FDA 510(k) premarket notification submitted by Surgify Medical OY for the device "Surgify Halo". The FDA issued a decision of Substantially Equivalent on November 29, 2023. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Surgify Medical OY has at least 3 other 510(k) clearances on record.