510(k) K180369

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) by Relievant Medsystems — Product Code GXI

K180369 is an FDA 510(k) premarket notification submitted by Relievant Medsystems for the device "Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)". The FDA issued a decision of Substantially Equivalent on September 14, 2018. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Relievant Medsystems has at least 9 other 510(k) clearances on record.