FDA product code GZF: Stimulator, Peripheral Nerve, Implanted (Pain Relief)
GZF is the FDA product code for stimulator, peripheral nerve, implanted (pain relief). It is a Class II device, regulated under 21 CFR 882.5870 and reviewed by the Neurology panel. FDA has cleared 25 510(k) submissions under GZF, 7 in the last five years, from 11 different applicants. The average 510(k) review took 184 days (median 175); 268 days on average over the last three years. FDA has posted 7 recalls for GZF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Device class | Class II |
| Regulation | 21 CFR 882.5870 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GZF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 87 |
| 2019 | 3 | 164 |
| 2020 | 2 | 82 |
| 2021 | 1 | 339 |
| 2022 | 1 | 244 |
| 2023 | 1 | 341 |
| 2024 | 2 | 322 |
| 2025 | 2 | 218 |
| 2026 | 1 | 265 |
Compare with all 510(k) review times · Search every GZF clearance
Top GZF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 8 | 2000-04-12 |
| Bioness, Inc. | 4 | 2022-02-23 |
| Bioventus, LLC | 3 | 2026-08-26 |
| Boston Scientific Neuromodulation | 2 | 2024-08-21 |
| Neuspera Medical, Inc. | 2 | 2023-04-11 |
6 more applicants have GZF clearances. See the full list in Caduvo.
Most recent GZF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253877 | Bioventus, LLC | StimTrial Neuromodulation System | 2026-08-26 | 265 |
| K243782 | Bioventus, LLC | StimTrial Neuromodulation System | 2025-07-16 | 219 |
| K243678 | Bioventus, LLC | TalisMann Neuromodulation System | 2025-07-03 | 218 |
| K232415 | Boston Scientific Neuromodulation | Nalu Neurostimulation System for Peripheral Nerve Stimulation | 2024-08-21 | 376 |
| K233162 | Curonix | Freedom Peripheral Nerve Stimulator (PNS) System | 2024-06-20 | 267 |
Recalls for GZF devices
7 product recalls in 2 recall events; 1 initiated in the last five years and 7 still open. Most recent: 2024-06-03.
| Year | Recalls |
|---|---|
| 2020 | 6 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code GZF?
GZF is the FDA product code for stimulator, peripheral nerve, implanted (pain relief). It is a Class II device, regulated under 21 CFR 882.5870 and reviewed by the Neurology panel.
What device class is GZF?
Class II, regulation 21 CFR 882.5870. Typical premarket route: 510(k).
How long does a 510(k) take for product code GZF?
Across 25 cleared submissions the average was 184 days from receipt to decision (median 175).
Which companies have the most GZF clearances?
Medtronic Vascular (8); Bioness, Inc. (4); Bioventus, LLC (3); Boston Scientific Neuromodulation (2); Neuspera Medical, Inc. (2).
Have GZF devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2024-06-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GZF
- Run a recall and safety report across every GZF manufacturer
- Watch product code GZF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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