510(k) K250213 ยท GXI Probe, Radiofrequency Lesion
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
| Applicant | Stryker Instruments, Portage MI, US |
| Decision | Substantially Equivalent, May 15, 2025 |
| Received | Jan 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250213
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.