Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
FDA 510(k) K190504 · Relievant Medsystems
510(k) numberK190504
Submission
- Device name
- Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
- Applicant
- Relievant Medsystems
Sunnyvale, CA, US - Received
- March 1, 2019
- Decision date
- May 3, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253907 | Disposable Radiofrequency CannulaGXI · Traditional | Abbott Medical | 04/16/2026SE |
| K251802 | STAR RF Ablation SystemGXI · Traditional | Merit Medical Systems, Inc. | 02/13/2026SE |
| K251243 | OneRF Trigeminal Nerve Radiofrequency ProbesGXI · Traditional | Neuroone Medical Technologies Corp. | 08/15/2025SE |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)GXI · Traditional | Abbott Medical | 05/27/2025SE |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…GXI · Traditional | Stryker Instruments | 05/15/2025SE |
| K241367 | RF CannulaGXI · Traditional | Shanghai Samedical & Plastic Instruments Co., Ltd. | 01/23/2025SE |
| K222281 | Intracept Intraosseous Nerve Ablation SystemGXI · Traditional | Relievant Medsystems, Inc. | 10/26/2022SE |
| K213836 | Intracept Intraosseous Nerve Ablation SystemGXI · Traditional | Relievant Medsystems, Inc. | 03/11/2022SE |
| K203066 | COOLIEF Cooled Radiofrequency Kit AdvancedGXI · Traditional | Avanos Medical, Inc. | 12/22/2020SE |
| K190259 | Vesta RF CannulaGXI · Special | Biomerics | 02/07/2020SE |
More from Biomerics
| 510(k) | Device | Decision |
|---|---|---|
| K222281 | Intracept Intraosseous Nerve Ablation SystemGXI · Traditional | 10/26/2022SE |
| K213836 | Intracept Intraosseous Nerve Ablation SystemGXI · Traditional | 03/11/2022SE |
| K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)GXI · Traditional | 09/14/2018SE |
| K171143 | Relievant Medsystems RF GeneratorGXD · Traditional | 08/18/2017SE |
| K170827 | INTRACEPT Intraosseous Nerve Ablation SystemGXI · Traditional | 08/09/2017SE |
| K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetGXI · Traditional | 07/09/2016SE |
| K100641 | Intracept Flexible Bi-Polar RF Probe and Easy Access Instrument Set, Model FG0018…GEI · Special | 03/30/2010SE |
| K083856 | Intracept Flexible Bi-Polar RF Probe and Curved Instrument Set, Models: FG0018, FG0026GEI · Special | 01/22/2009SE |
| K070443 | Intracept Bi-Polar RF Probe, Model 04814GEI · Traditional | 10/05/2007SE |
Questions and answers
When was Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator cleared by the FDA?
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator (K190504) received a 510(k) decision of Substantially Equivalent on May 3, 2019, 63 days after the submission was received.
What is the product code of K190504?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.