GXI · Probe, Radiofrequency Lesion
Neurology · 21 CFR 882.4725 · Class 2
Overview
| Product Code | GXI |
|---|---|
| Device Name | Probe, Radiofrequency Lesion |
| Regulation | 21 CFR 882.4725 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 66)
Showing 20 most recent of 66 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253907 | Disposable Radiofrequency Cannula | ABBOTT MEDICAL | Apr 16, 2026 | SESE |
| K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | Feb 13, 2026 | SESE |
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | Aug 15, 2025 | SESE |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | ABBOTT MEDICAL | May 27, 2025 | SESE |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) | Stryker Instruments | May 15, 2025 | SESE |
| K241367 | RF Cannula | Shanghai Samedical & Plastic Instruments Co., Ltd. | Jan 23, 2025 | SESE |
| K222281 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | Oct 26, 2022 | SESE |
| K213836 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | Mar 11, 2022 | SESE |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | Dec 22, 2020 | SESE |
| K190259 | Vesta RF Cannula | Biomerics | Feb 7, 2020 | SESE |
| K191293 | LCCS VC-S RF Cannula | Lccs Products Limited | Jan 24, 2020 | SESE |
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | Relievant Medsystems | May 3, 2019 | SESE |
| K190256 | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | Mar 8, 2019 | SESE |
| K183177 | Nitinol Thermocouple (TCN) Electrode | Boston Scientific Corporation | Mar 8, 2019 | SESE |
| K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems | Sep 14, 2018 | SESE |
| K170827 | INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems | Aug 9, 2017 | SESE |
| K170708 | OWL RF INSULATED CANNULAE | Diros Technology, Inc. | Jun 27, 2017 | SESE |
| K163461 | Coolief* Cooled RF Probe | Halyard Health, Inc. | Apr 13, 2017 | SESE |
| K163236 | COOLIEF Cooled Radiofrequency Kit | Halyard Health, Inc. | Dec 16, 2016 | SESE |
| K152642 | LCCS Disposable RF Electrode, LCCS Reusable RF Electrode | Lccs Products Limited | Aug 26, 2016 | SESE |
Top Applicants
- Baylis Medical Co., Inc. — 7 clearances
- Diros Technology, Inc. — 5 clearances
- Cosman Medical, Inc. — 4 clearances
- Relievant Medsystems — 4 clearances
- Smith & Nephew, Inc. — 4 clearances
