FDA Product Code
FDA Product Code GXI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4725
510(k) Clearances — 66 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253907 | Disposable Radiofrequency Cannula | ABBOTT MEDICAL | 2026-04-16 | Traditional | PDF ↗ |
| K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | 2026-02-13 | Traditional | PDF ↗ |
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | 2025-08-15 | Traditional | PDF ↗ |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | ABBOTT MEDICAL | 2025-05-27 | Traditional | PDF ↗ |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) | Stryker Instruments | 2025-05-15 | Traditional | PDF ↗ |
| K241367 | RF Cannula | Shanghai Samedical & Plastic Instruments Co., Ltd. | 2025-01-23 | Traditional | PDF ↗ |
| K222281 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022-10-26 | Traditional | PDF ↗ |
| K213836 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022-03-11 | Traditional | PDF ↗ |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | 2020-12-22 | Traditional | PDF ↗ |
| K190259 | Vesta RF Cannula | Biomerics | 2020-02-07 | Special | PDF ↗ |
| K191293 | LCCS VC-S RF Cannula | Lccs Products Limited | 2020-01-24 | Traditional | PDF ↗ |
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | Relievant Medsystems | 2019-05-03 | Traditional | PDF ↗ |
| K183177 | Nitinol Thermocouple (TCN) Electrode | Boston Scientific Corporation | 2019-03-08 | Special | PDF ↗ |
| K190256 | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | 2019-03-08 | Traditional | PDF ↗ |
| K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems | 2018-09-14 | Traditional | PDF ↗ |
| K170827 | INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems | 2017-08-09 | Traditional | PDF ↗ |
| K170708 | OWL RF INSULATED CANNULAE | Diros Technology, Inc. | 2017-06-27 | Special | PDF ↗ |
| K163461 | Coolief* Cooled RF Probe | Halyard Health, Inc. | 2017-04-13 | Traditional | PDF ↗ |
| K163236 | COOLIEF Cooled Radiofrequency Kit | Halyard Health, Inc. | 2016-12-16 | Traditional | PDF ↗ |
| K152642 | LCCS Disposable RF Electrode, LCCS Reusable RF Electrode | Lccs Products Limited | 2016-08-26 | Traditional | PDF ↗ |
| K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | Relievant Medsystems | 2016-07-09 | Traditional | PDF ↗ |
| K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH | Diros Technology, Inc. | 2015-07-30 | Traditional | PDF ↗ |
| K141586 | OWL CANNULAE | Diros Technology, Inc. | 2014-12-30 | Traditional | PDF ↗ |
| K123178 | STRYKER VENOM ELECTRODES AND CANNULAE | Stryker Instruments, Instruments Div. | 2013-03-28 | Traditional | PDF ↗ |
| K121773 | NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE | Biomerics | 2012-09-21 | Traditional | PDF ↗ |
| K112231 | LCCS INSULATED SPINAL NEEDLE (RF CANNULA) | Lccs Products Limited | 2011-08-19 | Traditional | PDF ↗ |
| K102566 | OWL CANNULAE | Diros Technology, Inc. | 2011-06-03 | Traditional | PDF ↗ |
| K110593 | OWL RF PROBES | Diros Technology, Inc. | 2011-05-05 | Special | PDF ↗ |
| K101372 | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 | Baylis Medical Co., Inc. | 2010-08-10 | Special | PDF ↗ |
| K090608 | MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) | Minta Medical Limited | 2010-06-14 | Traditional | PDF ↗ |
| K092337 | PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS | Baylis Medical Co., Inc. | 2009-10-16 | Special | PDF ↗ |
| K090955 | SMITH & NEPHEW RF CANNULATE | Smith & Nephew, Inc. | 2009-07-16 | Traditional | PDF ↗ |
| K080771 | TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC | Top Corp. | 2008-11-10 | Traditional | PDF ↗ |
| K082012 | COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN | Cosman Medical, Inc. | 2008-10-14 | Traditional | PDF ↗ |
| K071300 | MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE | Smith & Nephew, Inc. | 2007-07-20 | Traditional | PDF ↗ |
| K071745 | BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE | Baylis Medical Co., Inc. | 2007-07-19 | Special | PDF ↗ |
| K062946 | TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL | Top Corp. | 2007-02-15 | Traditional | PDF ↗ |
| K062937 | TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU | Baylis Medical Co., Inc. | 2007-01-08 | Traditional | PDF ↗ |
| K063467 | SMITH & NEPHEW RF CANNULAE | Smith & Nephew, Inc. | 2006-11-21 | Special | PDF ↗ |
| K060397 | RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED | PAJUNK GmbH Medizintechnologie | 2006-08-31 | Traditional | PDF ↗ |
| K060799 | COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA | Cosman Medical, Inc. | 2006-05-02 | Traditional | PDF ↗ |
| K053415 | LESIONPOINT RF CANNULA | Cosman Medical, Inc. | 2006-04-25 | Traditional | PDF ↗ |
| K053082 | BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 | Baylis Medical Co., Inc. | 2005-11-30 | Special | PDF ↗ |
| K043442 | STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE | Stryker Instruments | 2005-05-31 | Traditional | PDF ↗ |
| K050084 | COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; | Cosman Medical, Inc. | 2005-03-17 | Traditional | PDF ↗ |
| K042375 | SMK, CX, CXE, RCN | Technomed Europe | 2004-10-26 | Traditional | PDF ↗ |
| K041021 | RF INTRODUCTION CANNULA | Epimed International, Inc. | 2004-09-16 | Traditional | PDF ↗ |
| K032406 | STRYKER RF ELECTRODES AND CANNULAE | Stryker Instruments | 2004-04-01 | Traditional | PDF ↗ |
| K034012 | SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE | Smith & Nephew, Inc. | 2004-03-16 | Traditional | PDF ↗ |
| K032196 | NBD DISPOSABLE RF CANNULAE | New Business Development, LLC | 2003-10-09 | Traditional | PDF ↗ |
| K021942 | RADIONICS POLE NEEDLES | Radionics, A Division of Tyco Healthcare Group LP | 2002-09-11 | Traditional | PDF ↗ |
| K011387 | NEUROTHERM, MODEL JK4 | Eurolink, LLC | 2001-09-06 | Traditional | PDF ↗ |
| K002389 | BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY | Baylis Medical Co., Inc. | 2000-10-23 | Traditional | PDF ↗ |
| K001588 | ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20 | Arthrocare Corp. | 2000-08-17 | Traditional | PDF ↗ |
| K994344 | NEUROTHERM RF CANNULA | Rocket Medical Plc | 2000-03-21 | Traditional | PDF ↗ |
| K000073 | MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA | Mercury Medical | 2000-03-01 | Traditional | PDF ↗ |
| K991399 | RADIONICS MICROELECTRODE KIT | Radionics, Inc. | 1999-09-21 | Traditional | PDF ↗ |
| K972846 | BMC RF CANNULA | Baylis Medical Co., Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K980430 | RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998-03-16 | Traditional | PDF ↗ |
| K884347 | MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN | Advanced Surgical Products, Inc. | 1988-12-27 | Traditional | PDF ↗ |
| K882802 | STORZ DISPOSABLE BIPOLAR PENCILS | Storz Instrument Co. | 1988-08-17 | Traditional | PDF ↗ |
| K880925 | DISPOSABLE WET FIELD ERASER | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K880951 | DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K880293 | THE STORZ BIPOLAR PENCIL AND CORD | Storz Instrument Co. | 1988-03-17 | Traditional | PDF ↗ |
| K870028 | SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE | Radionics, Inc. | 1987-10-26 | Traditional | PDF ↗ |
| K802243 | VAXIOM FAMILY OF RF LESION PROBES & ELEC | Progress Mankind Technology | 1980-11-12 | Traditional | PDF ↗ |
Product code GXI · Class II · Neurology. Data: openFDA.