Eden Prairie, MN, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GZL | Electrode, Depth | Class II | Neurology | 2 | 2022-10-20 |
| GXI | Probe, Radiofrequency Lesion | Class II | Neurology | 1 | 2025-08-15 |
| GXD | Generator, Lesion, Radiofrequency | Class II | Neurology | 1 | 2023-12-06 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-08-15 | K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | GXI | Class II | Neurology |
| 2023-12-06 | K231675 | OneRF Ablation System | GXD | Class II | Neurology |
| 2022-10-20 | K222404 | Evo® sEEG System | GZL | Class II | Neurology |
| 2021-09-01 | K211367 | Evo sEEG System | GZL | Class II | Neurology |