510(k) K253826

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle by Galvanize Therapeutics, Inc. — Product Code OAB

K253826 is an FDA 510(k) premarket notification submitted by Galvanize Therapeutics, Inc. for the device "Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle". The FDA issued a decision of Substantially Equivalent on May 7, 2026. The device falls under product code OAB (Low Energy Direct Current Thermal Ablation System), a Class II device regulated under 21 CFR 878.4400. Galvanize Therapeutics, Inc. has at least 2 other 510(k) clearances on record.