GWF
- Product code
- GWF
- Device name
- Stimulator, Electrical, Evoked Response
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1870
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 140 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253301 | 2026-06-27 | Time IS Brain, S.L. | BraiN20® (BraiN20) | |
| K252842 | 2026-01-11 | Alphatec Spine, Inc. | SafeOp 3: Neural Informatix System | |
| K243982 | 2025-01-22 | Natus Neurology Incorporated | Nicolet EDX | |
| K243495 | 2024-12-12 | Natus Neurology Incorporated | Natus Ultrapro S100 (982A0594) | |
| K242345 | 2024-11-05 | Quantalx Neuroscience | Delphi Stimulator | |
| K234092 | 2024-04-19 | Alphatec Spine, Inc. | SafeOp 3: Neural Informatix Systeem | FDA |
| K234080 | 2024-03-25 | Soterix Medical, Inc. | MEGA-IOM system with Neuro-IOM.NET software (32/B - … | |
| K233292 | 2023-10-27 | Inomed Medizintechnik GmbH | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plu… |
Official FDA classification page: GWF
Classification and pathway per current FDA publications. Data from openFDA (CC0).