FDA Product Code
FDA Product Code GXD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4400
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | 2025-08-07 | Traditional | PDF ↗ |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | Avanos Medical, Inc. | 2024-08-14 | Special | PDF ↗ |
| K232632 | Racz Neurostat RF Generator | Epimed International | 2024-05-24 | Traditional | PDF ↗ |
| K231675 | OneRF Ablation System | Neuroone Medical Technologies Corp. | 2023-12-06 | Traditional | PDF ↗ |
| K220122 | APEX 6 | Rf Innovations, Inc. | 2023-03-15 | Traditional | PDF ↗ |
| K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | ABBOTT MEDICAL | 2022-01-21 | Traditional | PDF ↗ |
| K201610 | IonicRF Generator | ABBOTT MEDICAL | 2020-10-21 | Traditional | PDF ↗ |
| K192491 | Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. | 2020-02-21 | Traditional | PDF ↗ |
| K181864 | Polaris RF Ablation System | Baylis Medical Company, Inc. | 2019-01-02 | Traditional | PDF ↗ |
| K171143 | Relievant Medsystems RF Generator | Relievant Medsystems | 2017-08-18 | Traditional | PDF ↗ |
| K170242 | MultiGen 2 RF Generator System | Stryker Corporation | 2017-05-25 | Traditional | PDF ↗ |
| K101592 | ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM | Cheng Medical, Corporation | 2011-10-06 | Traditional | PDF ↗ |
| K111576 | NT 2000 LESIONING GENERATOR | Neuro Therm, Inc. | 2011-09-20 | Traditional | PDF ↗ |
| K093185 | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | Diros Technology, Inc. | 2010-01-22 | Traditional | PDF ↗ |
| K082051 | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 | Cosman Medical, Inc. | 2008-10-16 | Traditional | PDF ↗ |
| K081729 | MODIFICATION TO GFX NERVE ABLATION SYSTEM | Bioform Medical, Inc. | 2008-08-07 | Special | PDF ↗ |
| K071482 | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 | Synergetics, Inc. | 2007-12-20 | Traditional | PDF ↗ |
| K063753 | GFX NERVE ABLATION SYSTEM | Aci, Inc. | 2007-06-20 | Traditional | PDF ↗ |
| K070336 | STOCKERT NEURO N50, MODEL12267 | Stockert GmbH | 2007-06-14 | Traditional | PDF ↗ |
| K063489 | STRYKER INTRADISCAL RF GENERATOR | Synergetics, Inc. | 2007-05-23 | Traditional | PDF ↗ |
| K062758 | OWL URF-3AP | Diros Technology, Inc. | 2006-09-27 | Special | PDF ↗ |
| K052878 | NT-1000 | Neuro Therm, Inc. | 2006-01-23 | Traditional | PDF ↗ |
| K040565 | PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE | Physician Industries, Inc. | 2004-07-22 | Traditional | PDF ↗ |
| K032601 | STRYKER INTERVENTIONAL PAIN RF GENERATOR | Valley Forge Scientific Corp. | 2004-04-01 | Traditional | PDF ↗ |
| K021869 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP | Diros Technology, Inc. | 2002-07-01 | Special | PDF ↗ |
| K020354 | BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) | Baylis Medical Co., Inc. | 2002-05-03 | Traditional | PDF ↗ |
| K010202 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES | Leslie W. Organ | 2001-10-31 | Traditional | PDF ↗ |
| K002565 | BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) | Baylis Medical Co., Inc. | 2001-05-03 | Traditional | PDF ↗ |
| K010969 | NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES | Stryker Instruments | 2001-04-20 | Special | PDF ↗ |
| K983214 | RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES | Rita Medical Systems | 2000-03-27 | Traditional | PDF ↗ |
| K982489 | RFG-3C PLUS | Radionics, Inc. | 1998-10-05 | Traditional | PDF ↗ |
| K965182 | RFG-3CF | Radionics, Inc. | 1997-03-12 | Traditional | PDF ↗ |
| K963577 | RADIONICS SLUIJTER-MEHTA CANNULA | Radionics, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K941823 | LEKSELL NEURO GENERATOR AND ACCESSORIES | Elekta Instruments, Inc. | 1996-03-22 | Traditional | PDF ↗ |
| K922064 | MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE | Cardiotronics, Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K901540 | MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR | Radionics, Inc. | 1991-04-08 | Traditional | PDF ↗ |
| K896450 | NEURO N 50 LESION GENERATOR | Leibinger & Fischer , Ltd. | 1991-03-19 | Traditional | PDF ↗ |
Product code GXD · Class II · Neurology. Data: openFDA.