K251247 is an FDA 510(k) clearance for the GX1 Radiofrequency Generator Kit (RFG-X1-120V). This device is classified as a Generator, Lesion, Radiofrequency (Class II - Special Controls, product code GXD).
Submitted by Boston Scientific Neuromodulation Corporation (Valencia, US). The FDA issued a Cleared decision on August 7, 2025, 106 days after receiving the submission on April 23, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4400.
| 510(k) Number | K251247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2025 |
| Decision Date | August 07, 2025 |
| Days to Decision | 106 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 |