GWF — Stimulator, Electrical, Evoked Response Class II
FDA product code GWF covers "Stimulator, Electrical, Evoked Response", a Class II medical device regulated under 21 CFR 882.1870. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GWF
- Device Class
- Class II
- Regulation Number
- 882.1870
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253301 | time is brain, s.l | BraiN20® (BraiN20) | June 27, 2026 |
| K252842 | alphatec spine | SafeOp 3: Neural Informatix System | January 11, 2026 |
| K243982 | natus neurology incorporated | Nicolet EDX | January 22, 2025 |
| K243495 | natus neurology incorporated | Natus Ultrapro S100 (982A0594) | December 12, 2024 |
| K242345 | quantalx neuroscience | Delphi Stimulator | November 5, 2024 |
| K234092 | alphatec spine | SafeOp 3: Neural Informatix Systeem | April 19, 2024 |
| K234080 | soterix medical | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | March 25, 2024 |
| K233292 | inomed medizintechnik | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | October 27, 2023 |
| K230415 | cadwell industries | Cadwell Guardian | August 17, 2023 |
| K213849 | alphatec spine | SafeOp 2: Neural Informatix System | March 9, 2022 |
| K212166 | inomed medizintechnik | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | January 7, 2022 |
| K192823 | soterix medical | MEGA-TMS | August 13, 2021 |
| K190703 | neurosoft | Neuro-IOM system with Neuro-IOM.NET software | May 22, 2021 |
| K200759 | medtronic xomed | NIM Vital, Nerve Integrity Monitor | October 28, 2020 |
| K182542 | safeop surgical | The EPAD 2 System | February 22, 2019 |
| K170677 | neurovision medical product | Neurovision Nerve Locator Monitor (Nerveana), EMGView Software | April 5, 2017 |
| K162873 | tonica elektronik | MEP Monitor | March 31, 2017 |
| K162199 | cadwell industries | Cascade IOMAX Intraoperative Monitor | March 2, 2017 |
| K160280 | tonica elektronik | MagPro R20 | May 16, 2016 |
| K150220 | eb neuro | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast | August 19, 2015 |