Intracept Intraosseous Nerve Ablation System
FDA 510(k) K222281 · Relievant Medsystems, Inc.
510(k) numberK222281
Submission
- Device name
- Intracept Intraosseous Nerve Ablation System
- Applicant
- Relievant Medsystems, Inc.
Sunnyvale, CA, US - Received
- July 29, 2022
- Decision date
- October 26, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXI
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|---|---|---|---|
| K253907 | Disposable Radiofrequency CannulaGXI · Traditional | Abbott Medical | 04/16/2026SE |
| K251802 | STAR RF Ablation SystemGXI · Traditional | Merit Medical Systems, Inc. | 02/13/2026SE |
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| 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 |
| 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 |
| K191293 | LCCS VC-S RF CannulaGXI · Traditional | Lccs Products Limited | 01/24/2020SE |
More from Lccs Products Limited
| 510(k) | Device | Decision |
|---|---|---|
| K213836 | Intracept Intraosseous Nerve Ablation SystemGXI · Traditional | 03/11/2022SE |
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve…GXI · Traditional | 05/03/2019SE |
| 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 cleared by the FDA?
Intracept Intraosseous Nerve Ablation System (K222281) received a 510(k) decision of Substantially Equivalent on October 26, 2022, 89 days after the submission was received.
What is the product code of K222281?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.