K250213 is an FDA 510(k) clearance for the OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit). This device is classified as a Probe, Radiofrequency Lesion (Class II - Special Controls, product code GXI).
Submitted by Stryker Instruments (Portage, 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 FDA review panel. Regulated under 21 CFR 882.4725.
| 510(k) Number | K250213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2025 |
| Decision Date | May 15, 2025 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXI — Probe, Radiofrequency Lesion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4725 |