GXD · Generator, Lesion, Radiofrequency
Neurology · 21 CFR 882.4400 · Class 2
Overview
| Product Code | GXD |
|---|---|
| Device Name | Generator, Lesion, Radiofrequency |
| Regulation | 21 CFR 882.4400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | 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 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | Avanos Medical, Inc. | Aug 14, 2024 | SESE |
| K232632 | Racz Neurostat RF Generator | Epimed International | May 24, 2024 | SESE |
| K231675 | OneRF Ablation System | Neuroone Medical Technologies Corp. | Dec 6, 2023 | SESE |
| K220122 | APEX 6 | Rf Innovations, Inc. | Mar 15, 2023 | SESE |
| K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | ABBOTT MEDICAL | Jan 21, 2022 | SESE |
| K201610 | IonicRF Generator | ABBOTT MEDICAL | Oct 21, 2020 | SESE |
| K192491 | Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. | Feb 21, 2020 | SESE |
| K181864 | Polaris RF Ablation System | Baylis Medical Company, Inc. | Jan 2, 2019 | SESE |
| K171143 | Relievant Medsystems RF Generator | Relievant Medsystems | Aug 18, 2017 | SESE |
| K170242 | MultiGen 2 RF Generator System | Stryker Corporation | May 25, 2017 | SESE |
| K101592 | ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM | Cheng Medical, Corporation | Oct 6, 2011 | SESE |
| K111576 | NT 2000 LESIONING GENERATOR | Neuro Therm, Inc. | Sep 20, 2011 | SESE |
| K093185 | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | Diros Technology, Inc. | Jan 22, 2010 | SESE |
| K082051 | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 | Cosman Medical, Inc. | Oct 16, 2008 | SESE |
| K081729 | MODIFICATION TO GFX NERVE ABLATION SYSTEM | Bioform Medical, Inc. | Aug 7, 2008 | SESE |
| K071482 | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 | Synergetics, Inc. | Dec 20, 2007 | SESE |
| K063753 | GFX NERVE ABLATION SYSTEM | Aci, Inc. | Jun 20, 2007 | SESE |
| K070336 | STOCKERT NEURO N50, MODEL12267 | Stockert GmbH | Jun 14, 2007 | SESE |
| K063489 | 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
