Clearance Summary
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) received FDA 510(k) clearance under submission number K250213, sponsored by Stryker Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-05-15.
- Submission: K250213
- Applicant / Sponsor: Stryker Instruments
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4725
- Decision date: 2025-05-15
Classification & Regulation
This clearance is catalogued under FDA product code GXI and 21 CFR 882.4725, within the Neurology review panel as a Class II device.