Generator, Lesion, Radiofrequency
FDA product code GXD · Class II (moderate risk) · 21 CFR 882.4400 · Neurology
37510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Radionics, Inc. 4
- Diros Technology, Inc. 3
- Baylis Medical Co., Inc. 3
- Avanos Medical, Inc. 2
- Abbott Medical 2
- Synergetics Inc 2
- Neuro Therm, Inc. 2
- Leslie W. Organ 1
- Stryker Instruments 1
- Valley Forge Scientific Corp. 1
- Physician Industries, Inc. 1
- Rita Medical Systems, Inc. 1
- Elekta Instruments, Inc. 1
- Stockert GmbH 1
- Aci, Inc. 1
- Bioform Medical, Inc. 1
- Cosman Medical, Inc. 1
- Cheng Medical, Corporation 1
- Boston Scientific Neuromodulation Corporation 1
- Cardiotronics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…GXD · Traditional | Boston Scientific Neuromodulation Corporation | 08/07/2025SE |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)GXD · Special | Avanos Medical, Inc. | 08/14/2024SE |
| K232632 | Racz Neurostat RF GeneratorGXD · Traditional | Epimed International | 05/24/2024SE |
| K231675 | OneRF Ablation SystemGXD · Traditional | Neuroone Medical Technologies Corp. | 12/06/2023SE |
| K220122 | Apex 6GXD · Traditional | Rf Innovations, Inc. | 03/15/2023SE |
| K203293 | Abbott Medical Grounding Pad, model RF-DGP-ISGXD · Traditional | Abbott Medical | 01/21/2022SE |
| K201610 | IonicRF GeneratorGXD · Traditional | Abbott Medical | 10/21/2020SE |
| K192491 | Coolief Radiofrequency Generator (CRG) SystemGXD · Traditional | Avanos Medical, Inc. | 02/21/2020SE |
| K181864 | Polaris RF Ablation SystemGXD · Traditional | Baylis Medical Company, Inc. | 01/02/2019SE |
| K171143 | Relievant Medsystems RF GeneratorGXD · Traditional | Relievant Medsystems | 08/18/2017SE |
| K170242 | MultiGen 2 RF Generator SystemGXD · Traditional | Stryker Corporation | 05/25/2017SE |
| K101592 | Erase Hand- Held Controller; Erase Single Use Electric Catridge SystemGXD · Traditional | Cheng Medical, Corporation | 10/06/2011SE |
| K111576 | NT 2000 Lesioning GeneratorGXD · Traditional | Neuro Therm, Inc. | 09/20/2011SE |
| K093185 | Owl Universal RF System URF-3AP (ML)GXD · Traditional | Diros Technology, Inc. | 01/22/2010SE |
| K082051 | Cosman G4 Radiofrequency Generator, Model RFG-4GXD · Traditional | Cosman Medical, Inc. | 10/16/2008SE |
| K081729 | Modification to GFX Nerve Ablation SystemGXD · Special | Bioform Medical, Inc. | 08/07/2008SE |
| K071482 | Stryker RF Multi-Lesion Generator, Model 0406-900-000GXD · Traditional | Synergetics, Inc. | 12/20/2007SE |
| K063753 | GFX Nerve Ablation SystemGXD · Traditional | Aci, Inc. | 06/20/2007SE |
| K070336 | Stockert Neuro N50, MODEL12267GXD · Traditional | Stockert GmbH | 06/14/2007SE |
| K063489 | Stryker Intradiscal RF GeneratorGXD · Traditional | Synergetics, Inc. | 05/23/2007SE |
| K062758 | Owl URF-3APGXD · Special | Diros Technology, Inc. | 09/27/2006SE |
| K052878 | NT-1000GXD · Traditional | Neuro Therm, Inc. | 01/23/2006SE |
| K040565 | Physician Industries Radiofrequency Ablation NeedleGXD · Traditional | Physician Industries, Inc. | 07/22/2004SE |
| K032601 | Stryker Interventional Pain RF GeneratorGXD · Traditional | Valley Forge Scientific Corp. | 04/01/2004SE |
| K021869 | Owl Radiofrequency System, Model URF-2APGXD · Special | Diros Technology, Inc. | 07/01/2002SE |
| K020354 | Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230 (International)GXD · Traditional | Baylis Medical Co., Inc. | 05/03/2002SE |
| K010202 | Owl Radiofrequency System, Model URF-2A, and Associate Radiofrequency Lesion ProbesGXD · Traditional | Leslie W. Organ | 10/31/2001SE |
| K002565 | Baylis Pain Management Generator Model: PMG-115 (for Domestic Use), PMG-230 (for…GXD · Traditional | Baylis Medical Co., Inc. | 05/03/2001SE |
| K010969 | Neuro N100 Radiofrequency Generator and Accessory CablesGXD · Special | Stryker Instruments | 04/20/2001SE |
| K983214 | Rita RF Generator and Accessories, Model 500 SeriesGXD · Traditional | Rita Medical Systems | 03/27/2000SESU |
| K982489 | RFG-3C PlusGXD · Traditional | Radionics, Inc. | 10/05/1998SE |
| K965182 | RFG-3CFGXD · Traditional | Radionics, Inc. | 03/12/1997SE |
| K963577 | Radionics Sluijter-Mehta CannulaGXD · Traditional | Radionics, Inc. | 11/21/1996SE |
| K941823 | Leksell Neuro Generator and AccessoriesGXD · Traditional | Elekta Instruments, Inc. | 03/22/1996SE |
| K922064 | Model #510 Stealth-Plate Dispersive ElectrodeGXD · Traditional | Cardiotronics, Inc. | 12/01/1992SE |
| K901540 | Model RFG-3C Radiofrequency Lesion GeneratorGXD · Traditional | Radionics, Inc. | 04/08/1991SE |
| K896450 | Neuro N 50 Lesion GeneratorGXD · Traditional | Leibinger & Fischer , Ltd. | 03/19/1991SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0209-2024 Class II | Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generatorCertain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance… | Abbott | 09/28/2023Open, Classified |
| Z-2622-2023 Class II | COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent…Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and… | Avanos Medical, Inc. | 08/01/2023Completed |
| Z-1549-2021 Class II | NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000Potential capacitor failure which typically manifests as in inability to provide output on one or more… | Abbott Laboratories Inc. (St Jude Medical) | 04/22/2021Terminated |
| Z-0664-2020 Class II | Radiofrequency Grounding Pad, REF RF-DGP-LAffected lots were manufactured with the protective release liner in an incorrect orientation. When… | Abbott Medical | 10/14/2019Terminated |
| Z-0584-2017 Class III | RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000UStryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the… | Stryker Instruments Div. of Stryker… | 10/11/2016Terminated |
| Z-1361-2016 Class II | Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iXNT2000iX software shipped with the international setting turned on. The international settings include… | Neurotherm, Inc. | 10/09/2013Terminated |
| Z-0915-2011 | Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only…This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the… | Stryker Instruments Div. of Stryker… | 04/13/2010Terminated |