Product code GXI
- Device name
- Probe, Radiofrequency Lesion
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4725
- 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 |
|---|---|---|---|
| K253907 | Disposable Radiofrequency Cannula | ABBOTT MEDICAL | 2026-04-16 |
| K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | 2026-02-13 |
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | 2025-08-15 |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | ABBOTT MEDICAL | 2025-05-27 |
| 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 |
| K241367 | RF Cannula | Shanghai Samedical & Plastic Instruments Co., Ltd. | 2025-01-23 |
| K222281 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022-10-26 |
| K213836 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022-03-11 |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | 2020-12-22 |
| K190259 | Vesta RF Cannula | Biomerics | 2020-02-07 |
| K191293 | LCCS VC-S RF Cannula | Lccs Products Limited | 2020-01-24 |
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | Relievant Medsystems | 2019-05-03 |
| K190256 | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | 2019-03-08 |
| K183177 | Nitinol Thermocouple (TCN) Electrode | Boston Scientific Corporation | 2019-03-08 |
| K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems | 2018-09-14 |
| K170827 | INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems | 2017-08-09 |
| K170708 | OWL RF INSULATED CANNULAE | Diros Technology, Inc. | 2017-06-27 |
| K163461 | Coolief* Cooled RF Probe | Halyard Health, Inc. | 2017-04-13 |
| K163236 | COOLIEF Cooled Radiofrequency Kit | Halyard Health, Inc. | 2016-12-16 |
| K152642 | LCCS Disposable RF Electrode, LCCS Reusable RF Electrode | Lccs Products Limited | 2016-08-26 |
| K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | Relievant Medsystems | 2016-07-09 |
| K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH | Diros Technology, Inc. | 2015-07-30 |
| K141586 | OWL CANNULAE | Diros Technology, Inc. | 2014-12-30 |
| K123178 | STRYKER VENOM ELECTRODES AND CANNULAE | Stryker Instruments, Instruments Div. | 2013-03-28 |
| K121773 | NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE | Biomerics | 2012-09-21 |
| K112231 | LCCS INSULATED SPINAL NEEDLE (RF CANNULA) | Lccs Products Limited | 2011-08-19 |
| K102566 | OWL CANNULAE | Diros Technology, Inc. | 2011-06-03 |
| K110593 | OWL RF PROBES | Diros Technology, Inc. | 2011-05-05 |
| K101372 | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 | Baylis Medical Co., Inc. | 2010-08-10 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327118322 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118582 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118575 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118568 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118520 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118438 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118421 | Venom | STRYKER CORPORATION | 2016-09-23 |
| 07613327118414 | Venom | STRYKER CORPORATION | 2016-09-23 |
| 07613327118391 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118384 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118377 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118360 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118353 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118346 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118339 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118155 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118315 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118308 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118292 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118285 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118278 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118254 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118247 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118230 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118216 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118209 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118193 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118186 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118179 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327118162 | NA | STRYKER CORPORATION | 2016-09-23 |