K250213
- 510(k) number
- K250213
- Device name
- OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
- Applicant
- Stryker Instruments MI · US
- Product code
- GXI — Probe, Radiofrequency Lesion
- Decision date
- 2025-05-15
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250213.pdf
Official FDA record: K250213
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.