510(k) K251802

STAR RF Ablation System by Merit Medical Systems, Inc. — Product Code GXI

K251802 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "STAR RF Ablation System". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.