Home / Device Classification / GXI

GXI — Probe, Radiofrequency Lesion Class II

FDA Device Classification

Classification Details

Product Code
GXI
Device Class
Class II
Regulation Number
882.4725
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251802merit medical systemsSTAR RF Ablation SystemFebruary 13, 2026
K251243neuroone medical technologiesOneRF Trigeminal Nerve Radiofrequency ProbesAugust 15, 2025
K242841abbott medicalDisposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)May 27, 2025
K250213stryker instrumentsOptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlMay 15, 2025
K241367shanghai samedical and plastic instruments coRF CannulaJanuary 23, 2025
K222281relievant medsystemsIntracept Intraosseous Nerve Ablation SystemOctober 26, 2022
K213836relievant medsystemsIntracept Intraosseous Nerve Ablation SystemMarch 11, 2022
K203066avanos medicalCOOLIEF Cooled Radiofrequency Kit AdvancedDecember 22, 2020
K190259biomericsVesta RF CannulaFebruary 7, 2020
K191293lccs products limitedLCCS VC-S RF CannulaJanuary 24, 2020
K190504relievant medsystemsIntracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous May 3, 2019
K190256epimed internationalRulo Radiofrequency Lesion ProbeMarch 8, 2019
K183177boston scientific corporationNitinol Thermocouple (TCN) ElectrodeMarch 8, 2019
K180369relievant medsystemsIntracept Intraosseous Nerve Ablation System (component Intracept RF Probe)September 14, 2018
K170827relievant medsystemsINTRACEPT Intraosseous Nerve Ablation SystemAugust 9, 2017
K170708diros technologyOWL RF INSULATED CANNULAEJune 27, 2017
K163461halyard healthCoolief* Cooled RF ProbeApril 13, 2017
K163236halyard healthCOOLIEF Cooled Radiofrequency KitDecember 16, 2016
K152642lccs products limitedLCCS Disposable RF Electrode, LCCS Reusable RF ElectrodeAugust 26, 2016
K153272relievant medsystemsINTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetJuly 9, 2016