FDA 510(k) Applications for Medical Device Product Code "GXI"
(Probe, Radiofrequency Lesion)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K001588 | ARTHROCARE CORP. | ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20 | 08/17/2000 |
| K203066 | Avanos Medical, Inc. | COOLIEF Cooled Radiofrequency Kit Advanced | 12/22/2020 |
| K053082 | BAYLIS MEDICAL CO., INC. | BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 | 11/30/2005 |
| K002389 | BAYLIS MEDICAL CO., INC. | BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY | 10/23/2000 |
| K071745 | BAYLIS MEDICAL CO., INC. | BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE | 07/19/2007 |
| K972846 | BAYLIS MEDICAL CO., INC. | BMC RF CANNULA | 07/17/1998 |
| K101372 | BAYLIS MEDICAL CO., INC. | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 | 08/10/2010 |
| K092337 | BAYLIS MEDICAL CO., INC. | PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS | 10/16/2009 |
| K062937 | BAYLIS MEDICAL CO., INC. | TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU | 01/08/2007 |
| K121773 | BIOMERICS | NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE | 09/21/2012 |
| K190259 | Biomerics | Vesta RF Cannula | 02/07/2020 |
| K183177 | Boston Scientific Corporation | Nitinol Thermocouple (TCN) Electrode | 03/08/2019 |
| K060799 | COSMAN MEDICAL, INC. | COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA | 05/02/2006 |
| K082012 | COSMAN MEDICAL, INC. | COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN | 10/14/2008 |
| K050084 | COSMAN MEDICAL, INC. | COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; | 03/17/2005 |
| K053415 | COSMAN MEDICAL, INC. | LESIONPOINT RF CANNULA | 04/25/2006 |
| K170708 | Diros Technology Inc. | OWL RF INSULATED CANNULAE | 06/27/2017 |
| K150371 | DIROS TECHNOLOGY, INC. | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH | 07/30/2015 |
| K141586 | DIROS TECHNOLOGY, INC. | OWL CANNULAE | 12/30/2014 |
| K102566 | DIROS TECHNOLOGY, INC. | OWL CANNULAE | 06/03/2011 |
| K110593 | DIROS TECHNOLOGY, INC. | OWL RF PROBES | 05/05/2011 |
| K041021 | EPIMED INTERNATIONAL, INC. | RF INTRODUCTION CANNULA | 09/16/2004 |
| K190256 | Epimed International, Inc. | Rulo Radiofrequency Lesion Probe | 03/08/2019 |
| K011387 | EUROLINK LLC. | NEUROTHERM, MODEL JK4 | 09/06/2001 |
| K163236 | Halyard Health, Inc. | COOLIEF Cooled Radiofrequency Kit | 12/16/2016 |
| K163461 | Halyard Health, Inc. | Coolief* Cooled RF Probe | 04/13/2017 |
| K152642 | LCCS PRODUCTS LIMITED | LCCS Disposable RF Electrode, LCCS Reusable RF Electrode | 08/26/2016 |
| K112231 | LCCS PRODUCTS LIMITED | LCCS INSULATED SPINAL NEEDLE (RF CANNULA) | 08/19/2011 |
| K191293 | LCCS Products Limited | LCCS VC-S RF Cannula | 01/24/2020 |
| K000073 | MERCURY MEDICAL | MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA | 03/01/2000 |
| K090608 | MINTA MEDICAL LIMITED | MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) | 06/14/2010 |
| K032196 | NEW BUSINESS DEVELOPMENT, LLC | NBD DISPOSABLE RF CANNULAE | 10/09/2003 |
| K060397 | PAJUNK GMBH MEDIZINTECHNOLOGIE | RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED | 08/31/2006 |
| K021942 | RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP | RADIONICS POLE NEEDLES | 09/11/2002 |
| K980430 | RADIONICS, INC. | RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS) | 03/16/1998 |
| K991399 | RADIONICS, INC. | RADIONICS MICROELECTRODE KIT | 09/21/1999 |
| K153272 | RELIEVANT MEDSYSTEMS | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | 07/09/2016 |
| K170827 | Relievant Medsystems | INTRACEPT Intraosseous Nerve Ablation System | 08/09/2017 |
| K180369 | Relievant Medsystems | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | 09/14/2018 |
| K190504 | Relievant Medsystems | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | 05/03/2019 |
| K213836 | Relievant Medsystems, Inc. | Intracept Intraosseous Nerve Ablation System | 03/11/2022 |
| K222281 | Relievant Medsystems, Inc. | Intracept Intraosseous Nerve Ablation System | 10/26/2022 |
| K994344 | ROCKET MEDICAL PLC | NEUROTHERM RF CANNULA | 03/21/2000 |
| K071300 | SMITH & NEPHEW, INC. | MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE | 07/20/2007 |
| K063467 | SMITH & NEPHEW, INC. | SMITH & NEPHEW RF CANNULAE | 11/21/2006 |
| K090955 | SMITH & NEPHEW, INC. | SMITH & NEPHEW RF CANNULATE | 07/16/2009 |
| K034012 | SMITH & NEPHEW, INC. | SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE | 03/16/2004 |
| K043442 | STRYKER INSTRUMENTS | STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE | 05/31/2005 |
| K032406 | STRYKER INSTRUMENTS | STRYKER RF ELECTRODES AND CANNULAE | 04/01/2004 |
| K123178 | STRYKER INSTRUMENTS, INSTRUMENTS DIV. | STRYKER VENOM ELECTRODES AND CANNULAE | 03/28/2013 |
| K042375 | TECHNOMED EUROPE | SMK, CX, CXE, RCN | 10/26/2004 |
| K080771 | TOP CORP. | TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC | 11/10/2008 |
| K062946 | TOP CORP. | TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL | 02/15/2007 |
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