FDA 510(k)

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set

N.º K: K153272 · 2016-07-09

Fecha de decisión2016-07-09

Código de productoGXI

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set is the device name listed in this FDA 510(k) record. The listed applicant is Relievant Medsystems. It received FDA 510(k) clearance on 2016-07-09 under 510(k) number K153272. 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 Flexible Bi-Polar RF Probe and Easy Access Instrument Set?

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set is a medical device that received FDA 510(k) clearance on 2016-07-09. The listed applicant is Relievant Medsystems. The 510(k) number is K153272.

When did INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set receive FDA 510(k) clearance?

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set received FDA 510(k) clearance on 2016-07-09, under 510(k) number K153272.

Who is the listed applicant for INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set?

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 Flexible Bi-Polar RF Probe and Easy Access Instrument Set?

The FDA product code for INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set is GXI.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Relievant Medsystems como solicitante

K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)K171143Relievant Medsystems RF Generator K170827INTRACEPT Intraosseous Nerve Ablation System

Dispositivos relacionados (Código: GXI)

K253907Disposable Radiofrequency CannulaABBOTT MEDICAL K251802STAR 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 MEDICAL K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker Instruments K241367RF 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.