Data / Medical devices / United States / Neuroone Medical Technologies Corp.
Neuroone Medical Technologies Corp.: FDA-registered device maker in Eden Prairie, MN, United States, 5 510(k) clearances
Neuroone Medical Technologies Corp. is registered with the FDA (registration 3016438686) in Eden Prairie, MN, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016438686
- Address
- 7599 Anagram Drive, Eden Prairie, MN, United States, 55344
- Owner or operator
- NeuroOne Medical Technologies Corp. (10062284)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 8, 2020
- Registered through
- 2026
- Brand names listed
- EVO sEEG System, OneRF Ablation System, OneRF Trigeminal Nerve Radiofrequency Probes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cortical | GYC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrode, Depth | GZL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Generator, Lesion, Radiofrequency | GXD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Probe, Radiofrequency Lesion | GXI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 15, 2025 | K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | GXI | Substantially Equivalent | Neuroone Medical Technologies Corp. | accessdata.fda.gov |
| December 6, 2023 | K231675 | OneRF Ablation System | GXD | Substantially Equivalent | Neuroone Medical Technologies Corp. | accessdata.fda.gov |
| October 20, 2022 | K222404 | Evo® sEEG System | GZL | Substantially Equivalent | Neuroone Medical Technologies Corp. | accessdata.fda.gov |
| September 1, 2021 | K211367 | Evo sEEG System | GZL | Substantially Equivalent | Neuroone Medical Technologies Corp. | accessdata.fda.gov |
| November 26, 2019 | K192764 | NeuroOne Cortical Electrode | GYC | Substantially Equivalent | Neuroone, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Depth
- All makers of Probe, Radiofrequency Lesion
- All makers of Generator, Lesion, Radiofrequency
- All makers of Electrode, Cortical
Updated August 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.