GWF — Stimulator, Electrical, Evoked Response Class II
FDA Device Classification
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 |
|---|
| 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 |
| K142624 | nihon kohden corporation | Neuromaster G1 MEE200 | April 24, 2015 |