FDA 510(k)

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)

Número K: K180369 · 2018-09-14

Data da decisão2018-09-14

Código do produtoGXI

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) is the device name listed in this FDA 510(k) record. The listed applicant is Relievant Medsystems. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K180369. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)?

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Relievant Medsystems. The 510(k) number is K180369.

When did Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) receive FDA 510(k) clearance?

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) received FDA 510(k) clearance on 2018-09-14, under 510(k) number K180369.

Who is the listed applicant for Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)?

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 (component Intracept RF Probe)?

The FDA product code for Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) is GXI.

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Outros registros que listam Relievant Medsystems como candidato(a)

K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator K171143Relievant Medsystems RF Generator K170827INTRACEPT Intraosseous Nerve Ablation System K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set

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.

Fonte oficial

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