Product code GXD
- Device name
- Generator, Lesion, Radiofrequency
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4400
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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); G... | Boston Scientific Neuromodulation Corporation | 2025-08-07 |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | Avanos Medical, Inc. | 2024-08-14 |
| K232632 | Racz Neurostat RF Generator | Epimed International | 2024-05-24 |
| K231675 | OneRF Ablation System | Neuroone Medical Technologies Corp. | 2023-12-06 |
| K220122 | APEX 6 | Rf Innovations, Inc. | 2023-03-15 |
| K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | ABBOTT MEDICAL | 2022-01-21 |
| K201610 | IonicRF Generator | ABBOTT MEDICAL | 2020-10-21 |
| K192491 | Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. | 2020-02-21 |
| K181864 | Polaris RF Ablation System | Baylis Medical Company, Inc. | 2019-01-02 |
| K171143 | Relievant Medsystems RF Generator | Relievant Medsystems | 2017-08-18 |
| K170242 | MultiGen™ 2 RF Generator System | Stryker Corporation | 2017-05-25 |
| K101592 | ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM | Cheng Medical, Corporation | 2011-10-06 |
| K111576 | NT 2000 LESIONING GENERATOR | Neuro Therm, Inc. | 2011-09-20 |
| K093185 | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | Diros Technology, Inc. | 2010-01-22 |
| K082051 | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 | Cosman Medical, Inc. | 2008-10-16 |
| K081729 | MODIFICATION TO GFX NERVE ABLATION SYSTEM | Bioform Medical, Inc. | 2008-08-07 |
| K071482 | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 | Synergetics, Inc. | 2007-12-20 |
| K063753 | GFX NERVE ABLATION SYSTEM | Aci, Inc. | 2007-06-20 |
| K070336 | STOCKERT NEURO N50, MODEL12267 | Stockert GmbH | 2007-06-14 |
| K063489 | STRYKER INTRADISCAL RF GENERATOR | Synergetics, Inc. | 2007-05-23 |
| K062758 | OWL URF-3AP | Diros Technology, Inc. | 2006-09-27 |
| K052878 | NT-1000 | Neuro Therm, Inc. | 2006-01-23 |
| K040565 | PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE | Physician Industries, Inc. | 2004-07-22 |
| K032601 | STRYKER INTERVENTIONAL PAIN RF GENERATOR | Valley Forge Scientific Corp. | 2004-04-01 |
| K021869 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP | Diros Technology, Inc. | 2002-07-01 |
| K020354 | BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) | Baylis Medical Co., Inc. | 2002-05-03 |
| K010202 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES | Leslie W. Organ | 2001-10-31 |
| K002565 | BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) | Baylis Medical Co., Inc. | 2001-05-03 |
| K010969 | NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES | Stryker Instruments | 2001-04-20 |
| K983214 | RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES | Rita Medical Systems | 2000-03-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10195327563424 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2024-03-03 |
| 08714729972495 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2018-02-02 |
| 08714729972488 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2018-02-02 |
| 08714729972471 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2018-02-02 |
| 08714729972464 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2018-02-02 |
| 08714729972457 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2018-02-02 |
| 08714729972440 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2018-02-02 |
| 08714729967903 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-09-11 |
| 08714729968146 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-09-11 |
| 08714729968122 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-09-11 |
| 08714729968115 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-09-11 |
| 08714729968108 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-09-11 |
| 08714729967934 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-09-11 |
| 08714729967927 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-09-11 |
| 08714729967910 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-09-11 |
| 08714729967897 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-09-11 |
| 08714729968139 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-09-11 |
| 00813250011685 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250011593 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250011531 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250011470 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250011364 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250011296 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250010602 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250010589 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250010565 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250010442 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250010411 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250010107 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |
| 00813250010091 | NA | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2017-08-21 |