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FDA 510(k)

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

N.º K: K190504 · 2019-05-03

SolicitanteRelievant Medsystems
Fecha de decisión2019-05-03
Código de productoGXI
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator is the device name listed in this FDA 510(k) record. The listed applicant is Relievant Medsystems. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190504. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Relievant Medsystems. The 510(k) number is K190504.

When did Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator receive FDA 510(k) clearance?

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190504.

Who is the listed applicant for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

The FDA 510(k) record lists Relievant Medsystems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

The FDA product code for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator is GXI.

Ensayos clínicos relacionados

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NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Relievant Medsystems como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)K171143Relievant Medsystems RF GeneratorK170827INTRACEPT Intraosseous Nerve Ablation SystemK153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set

Dispositivos relacionados (Código: GXI)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K253907Disposable Radiofrequency CannulaABBOTT MEDICALK251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICALK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker InstrumentsK241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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