GZF
- Product code
- GZF
- Device name
- Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5870
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 25 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253877 | 2026-08-26 | Bioventus, LLC | StimTrial Neuromodulation System | |
| K243782 | 2025-07-16 | Bioventus, LLC | StimTrial Neuromodulation System | |
| K243678 | 2025-07-03 | Bioventus, LLC | TalisMann Neuromodulation System | |
| K232415 | 2024-08-21 | Boston Scientific Neuromodulation | Nalu Neurostimulation System for Peripheral Nerve St | |
| K233162 | 2024-06-20 | Curonix | Freedom Peripheral Nerve Stimulator (PNS) System | FDA |
Official FDA classification page: GZF
Classification and pathway per current FDA publications. Data from openFDA (CC0).