FDA.report

510(k) K251243

Device
OneRF Trigeminal Nerve Radiofrequency Probes
Applicant
Neuroone Medical Technologies Corp.
510(k) number
K251243
Product code
GXI
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-15
Date received
2025-04-22
Regulation
882.4725
Classification name
Probe, Radiofrequency Lesion
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Debra Kridner
Address
7599 Anagram Dr. Eden Prairie MN US 55344 55344

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code GXI

510(k)DeviceApplicantDecision date
K253907Disposable Radiofrequency CannulaABBOTT MEDICAL2026-04-16
K251802STAR RF Ablation SystemMerit Medical Systems, Inc.2026-02-13
K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICAL2025-05-27
K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker Instruments2025-05-15
K241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.2025-01-23
K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.2022-10-26
K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.2022-03-11
K203066COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc.2020-12-22
K190259Vesta RF CannulaBiomerics2020-02-07
K191293LCCS VC-S RF CannulaLccs Products Limited2020-01-24
K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF GeneratorRelievant Medsystems2019-05-03
K190256Rulo Radiofrequency Lesion ProbeEpimed International, Inc.2019-03-08
K183177Nitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation2019-03-08
K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems2018-09-14
K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems2017-08-09