K231675 is an FDA 510(k) clearance for the OneRF Ablation System. This device is classified as a Generator, Lesion, Radiofrequency (Class II - Special Controls, product code GXD).
Submitted by Neuroone Medical Technologies Corp. (Eden Prairie, US). The FDA issued a Cleared decision on December 6, 2023, 181 days after receiving the submission on June 8, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4400.
| 510(k) Number | K231675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2023 |
| Decision Date | December 06, 2023 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXD - Generator, Lesion, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4400 |