FDA 510(k)

STAR RF Ablation System

K号: K251802 · 2026-02-13

决定日期2026-02-13

产品代码GXI

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决定实质等同

器械摘要

STAR RF Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251802. 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 STAR RF Ablation System?

STAR RF Ablation System is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K251802.

When did STAR RF Ablation System receive FDA 510(k) clearance?

STAR RF Ablation System received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251802.

Who is the listed applicant for STAR RF Ablation System?

FDA 510(k)记录中列出了Merit Medical Systems, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for STAR RF Ablation System?

The FDA product code for STAR RF Ablation System is GXI.

列明Merit Medical Systems, Inc.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。

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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 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.K222281Intracept 骨内神经消融系统Relievant Medsystems, Inc.

官方来源

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