FDA 510(k) Applications for Medical Device Product Code "GXD"
(Generator, Lesion, Radiofrequency)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K203293 | Abbott Medical | Abbott Medical Grounding Pad, model RF-DGP-IS | 01/21/2022 |
| K201610 | Abbott Medical | IonicRF Generator | 10/21/2020 |
| K063753 | ACI, INC. | GFX NERVE ABLATION SYSTEM | 06/20/2007 |
| K192491 | Avanos Medical, Inc. | Coolief Radiofrequency Generator (CRG) System | 02/21/2020 |
| K020354 | BAYLIS MEDICAL CO., INC. | BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) | 05/03/2002 |
| K002565 | BAYLIS MEDICAL CO., INC. | BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) | 05/03/2001 |
| K181864 | Baylis Medical Company Inc. | Polaris RF Ablation System | 01/02/2019 |
| K081729 | BIOFORM MEDICAL, INC. | MODIFICATION TO GFX NERVE ABLATION SYSTEM | 08/07/2008 |
| K101592 | CHENG MEDICAL, CORPORATION | ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM | 10/06/2011 |
| K082051 | COSMAN MEDICAL, INC. | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 | 10/16/2008 |
| K021869 | DIROS TECHNOLOGY, INC. | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP | 07/01/2002 |
| K093185 | DIROS TECHNOLOGY, INC. | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | 01/22/2010 |
| K062758 | DIROS TECHNOLOGY, INC. | OWL URF-3AP | 09/27/2006 |
| K941823 | ELEKTA INSTRUMENTS, INC. | LEKSELL NEURO GENERATOR AND ACCESSORIES | 03/22/1996 |
| K010202 | LESLIE W. ORGAN | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES | 10/31/2001 |
| K111576 | NEUROTHERM, INC. | NT 2000 LESIONING GENERATOR | 09/20/2011 |
| K052878 | NEUROTHERM, INC. | NT-1000 | 01/23/2006 |
| K040565 | PHYSICIAN INDUSTRIES, INC. | PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE | 07/22/2004 |
| K963577 | RADIONICS, INC. | RADIONICS SLUIJTER-MEHTA CANNULA | 11/21/1996 |
| K982489 | RADIONICS, INC. | RFG-3C PLUS | 10/05/1998 |
| K965182 | RADIONICS, INC. | RFG-3CF | 03/12/1997 |
| K171143 | Relievant Medsystems | Relievant Medsystems RF Generator | 08/18/2017 |
| K220122 | RF Innovations, Inc | APEX 6 | 03/15/2023 |
| K983214 | RITA MEDICAL SYSTEMS | RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES | 03/27/2000 |
| K070336 | STOCKERT GMBH | STOCKERT NEURO N50, MODEL12267 | 06/14/2007 |
| K170242 | STRYKER CORPORATION | MultiGenÖ 2 RF Generator System | 05/25/2017 |
| K010969 | STRYKER INSTRUMENTS | NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES | 04/20/2001 |
| K071482 | SYNERGETICS, INC | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 | 12/20/2007 |
| K063489 | SYNERGETICS, INC. | STRYKER INTRADISCAL RF GENERATOR | 05/23/2007 |
| K032601 | VALLEY FORGE SCIENTIFIC CORP. | STRYKER INTERVENTIONAL PAIN RF GENERATOR | 04/01/2004 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
