510(k) K190504

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator by Relievant Medsystems — Product Code GXI

K190504 is an FDA 510(k) premarket notification submitted by Relievant Medsystems for the device "Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator". The FDA issued a decision of Substantially Equivalent on May 3, 2019. 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.