OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)

About This 510(k) Submission

K250213 is an FDA 510(k) clearance for the OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit), a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on May 15, 2025, 111 days after receiving the submission on January 24, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.