GXI — Probe, Radiofrequency Lesion Class II
FDA product code GXI covers "Probe, Radiofrequency Lesion", a Class II medical device regulated under 21 CFR 882.4725. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXI
- Device Class
- Class II
- Regulation Number
- 882.4725
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253907 | abbott medical | Disposable Radiofrequency Cannula | April 16, 2026 |
| K251802 | merit medical systems | STAR RF Ablation System | February 13, 2026 |
| K251243 | neuroone medical technologies | OneRF Trigeminal Nerve Radiofrequency Probes | August 15, 2025 |
| K242841 | abbott medical | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | May 27, 2025 |
| K250213 | stryker instruments | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBl | May 15, 2025 |
| K241367 | shanghai samedical and plastic instruments co | RF Cannula | January 23, 2025 |
| K222281 | relievant medsystems | Intracept Intraosseous Nerve Ablation System | October 26, 2022 |
| K213836 | relievant medsystems | Intracept Intraosseous Nerve Ablation System | March 11, 2022 |
| K203066 | avanos medical | COOLIEF Cooled Radiofrequency Kit Advanced | December 22, 2020 |
| K190259 | biomerics | Vesta RF Cannula | February 7, 2020 |
| K191293 | lccs products limited | LCCS VC-S RF Cannula | January 24, 2020 |
| K190504 | relievant medsystems | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous | May 3, 2019 |
| K183177 | boston scientific corporation | Nitinol Thermocouple (TCN) Electrode | March 8, 2019 |
| K190256 | epimed international | Rulo Radiofrequency Lesion Probe | March 8, 2019 |
| K180369 | relievant medsystems | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | September 14, 2018 |
| K170827 | relievant medsystems | INTRACEPT Intraosseous Nerve Ablation System | August 9, 2017 |
| K170708 | diros technology | OWL RF INSULATED CANNULAE | June 27, 2017 |
| K163461 | halyard health | Coolief* Cooled RF Probe | April 13, 2017 |
| K163236 | halyard health | COOLIEF Cooled Radiofrequency Kit | December 16, 2016 |
| K152642 | lccs products limited | LCCS Disposable RF Electrode, LCCS Reusable RF Electrode | August 26, 2016 |