510(k) K250213

OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) by Stryker Instruments — Product Code GXI

K250213 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)". The FDA issued a decision of Substantially Equivalent on May 15, 2025. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Stryker Instruments has at least 10 other 510(k) clearances on record.