Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4725](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4725) → GXI — Probe, Radiofrequency Lesion # GXI · Probe, Radiofrequency Lesion _Neurology · 21 CFR 882.4725 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI ## Overview - **Product Code:** GXI - **Device Name:** Probe, Radiofrequency Lesion - **Regulation:** [21 CFR 882.4725](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4725) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K253907.md) | Disposable Radiofrequency Cannula | ABBOTT MEDICAL | Apr 16, 2026 | SESE | | [K251802](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K251802.md) | STAR RF Ablation System | Merit Medical Systems, Inc. | Feb 13, 2026 | SESE | | [K251243](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K251243.md) | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | Aug 15, 2025 | SESE | | [K242841](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K242841.md) | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | ABBOTT MEDICAL | May 27, 2025 | SESE | | [K250213](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K250213.md) | 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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K241367.md) | RF Cannula | Shanghai Samedical & Plastic Instruments Co., Ltd. | Jan 23, 2025 | SESE | | [K222281](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K222281.md) | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | Oct 26, 2022 | SESE | | [K213836](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K213836.md) | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | Mar 11, 2022 | SESE | | [K203066](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K203066.md) | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | Dec 22, 2020 | SESE | | [K190259](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K190259.md) | Vesta RF Cannula | Biomerics | Feb 7, 2020 | SESE | | [K191293](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K191293.md) | LCCS VC-S RF Cannula | Lccs Products Limited | Jan 24, 2020 | SESE | | [K190504](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K190504.md) | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | Relievant Medsystems | May 3, 2019 | SESE | | [K190256](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K190256.md) | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | Mar 8, 2019 | SESE | | [K183177](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K183177.md) | Nitinol Thermocouple (TCN) Electrode | Boston Scientific Corporation | Mar 8, 2019 | SESE | | [K180369](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K180369.md) | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems | Sep 14, 2018 | SESE | | [K170827](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K170827.md) | INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems | Aug 9, 2017 | SESE | | [K170708](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K170708.md) | OWL RF INSULATED CANNULAE | Diros Technology, Inc. | Jun 27, 2017 | SESE | | [K163461](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K163461.md) | Coolief* Cooled RF Probe | Halyard Health, Inc. | Apr 13, 2017 | SESE | | [K163236](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K163236.md) | COOLIEF Cooled Radiofrequency Kit | Halyard Health, Inc. | Dec 16, 2016 | SESE | | [K152642](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI/K152642.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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