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510(k) K190504

Device
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
Applicant
Relievant Medsystems
510(k) number
K190504
Product code
GXI  
Decision
Substantially Equivalent (SESE)
Decision date
2019-05-03
Date received
2019-03-01
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
No

Applicant Contact#

Contact
Alex DiNello
Address
358 Moffett Park Dr., Suite 105 Sunnyvale CA US 94089 94089

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253907Disposable Radiofrequency CannulaABBOTT MEDICAL2026-04-16
K251802STAR RF Ablation SystemMerit Medical Systems, Inc.2026-02-13
K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.2025-08-15
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
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

Legacy Summary#

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FDA Review#

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