510(k) K253877 ยท GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
StimTrial Neuromodulation System
| Applicant | Bioventus, LLC, Durham NC, US |
| Decision | Substantially Equivalent, Aug 26, 2026 |
| Received | Dec 4, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253877
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.