Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4400](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4400) → GXD — Generator, Lesion, Radiofrequency # GXD · Generator, Lesion, Radiofrequency _Neurology · 21 CFR 882.4400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD ## Overview - **Product Code:** GXD - **Device Name:** Generator, Lesion, Radiofrequency - **Regulation:** [21 CFR 882.4400](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4400) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 37) Showing 20 most recent of 37 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251247](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K251247.md) | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) | Boston Scientific Neuromodulation Corporation | Aug 7, 2025 | SESE | | [K242057](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K242057.md) | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | Avanos Medical, Inc. | Aug 14, 2024 | SESE | | [K232632](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K232632.md) | Racz Neurostat RF Generator | Epimed International | May 24, 2024 | SESE | | [K231675](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K231675.md) | OneRF Ablation System | Neuroone Medical Technologies Corp. | Dec 6, 2023 | SESE | | [K220122](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K220122.md) | APEX 6 | Rf Innovations, Inc. | Mar 15, 2023 | SESE | | [K203293](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K203293.md) | Abbott Medical Grounding Pad, model RF-DGP-IS | ABBOTT MEDICAL | Jan 21, 2022 | SESE | | [K201610](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K201610.md) | IonicRF Generator | ABBOTT MEDICAL | Oct 21, 2020 | SESE | | [K192491](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K192491.md) | Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. | Feb 21, 2020 | SESE | | [K181864](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K181864.md) | Polaris RF Ablation System | Baylis Medical Company, Inc. | Jan 2, 2019 | SESE | | [K171143](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K171143.md) | Relievant Medsystems RF Generator | Relievant Medsystems | Aug 18, 2017 | SESE | | [K170242](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K170242.md) | MultiGen™ 2 RF Generator System | Stryker Corporation | May 25, 2017 | SESE | | [K101592](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K101592.md) | ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM | Cheng Medical, Corporation | Oct 6, 2011 | SESE | | [K111576](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K111576.md) | NT 2000 LESIONING GENERATOR | Neuro Therm, Inc. | Sep 20, 2011 | SESE | | [K093185](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K093185.md) | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | Diros Technology, Inc. | Jan 22, 2010 | SESE | | [K082051](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K082051.md) | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 | Cosman Medical, Inc. | Oct 16, 2008 | SESE | | [K081729](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K081729.md) | MODIFICATION TO GFX NERVE ABLATION SYSTEM | Bioform Medical, Inc. | Aug 7, 2008 | SESE | | [K071482](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K071482.md) | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 | Synergetics, Inc. | Dec 20, 2007 | SESE | | [K063753](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K063753.md) | GFX NERVE ABLATION SYSTEM | Aci, Inc. | Jun 20, 2007 | SESE | | [K070336](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K070336.md) | STOCKERT NEURO N50, MODEL12267 | Stockert GmbH | Jun 14, 2007 | SESE | | [K063489](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD/K063489.md) | STRYKER INTRADISCAL RF GENERATOR | Synergetics, Inc. | May 23, 2007 | SESE | ## Top Applicants - Radionics, Inc. — 4 clearances - Diros Technology, Inc. — 3 clearances - ABBOTT MEDICAL — 2 clearances - Avanos Medical, Inc. — 2 clearances - Baylis Medical Co., Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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