510(k) K213836

Intracept Intraosseous Nerve Ablation System by Relievant Medsystems, Inc. — Product Code GXI

K213836 is an FDA 510(k) premarket notification submitted by Relievant Medsystems, Inc. for the device "Intracept Intraosseous Nerve Ablation System". The FDA issued a decision of Substantially Equivalent on March 11, 2022. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Relievant Medsystems, Inc. has at least 9 other 510(k) clearances on record.