FDA 510(k)

Intracept 骨内神经消融系统（组件 Intracept 射频探头）

K号: K180369 · 2018-09-14

决定日期2018-09-14

产品代码GXI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Relievant Medsystems为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K190504Intracept 骨内神经消融系统（射频探头），Intracept 骨内神经消融系统（Access 工具），Relievant 射频发生器 K171143Relievant Medsystems RF 发生器 K170827INTRACEPT Intraosseous Nerve Ablation System K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set

相关器械（代码：GXI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253907一次性射频消融电极ABBOTT MEDICAL K251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF 三叉神经射频探针Neuroone Medical Technologies Corp.K242841一次性射频电极（RFDE-5/RFDE-10/RFDE-15/RFDE-20）ABBOTT MEDICAL K250213OptaBlate BVN 骨内神经消融系统（10mm探头单套件）；OptaBlate BVN 骨内神经消融系统（10mm探头双套件）Stryker Instruments K241367使用多叉电极与传统电极进行腰椎椎间盘突出症射频消融的比较Shanghai Samedical & Plastic Instruments Co., Ltd.

官方来源

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