FDA 510(k)

一次性射频电极（RFDE-5/RFDE-10/RFDE-15/RFDE-20）

K号: K242841 · 2025-05-27

决定日期2025-05-27

产品代码GXI

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决定实质等同

器械摘要

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-05-27 under 510(k) number K242841. 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 Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)?

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) is a medical device that received FDA 510(k) clearance on 2025-05-27. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K242841.

When did Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) receive FDA 510(k) clearance?

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) received FDA 510(k) clearance on 2025-05-27, under 510(k) number K242841.

Who is the listed applicant for Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)?

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

What is the FDA product code for Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)?

The FDA product code for Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) is GXI.

列明ABBOTT MEDICAL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。

K261729EnSite™ X EP系统 K262006EnSite™ X EP系统 K261631Amplatzer TorqVue 交换系统 K253459OPTIS 移动 Next 成像系统 (1014932)；OPTIS 集成 Next 成像系统 (1014933)；Ultreon 3.0 软件升级套件 (ULTR300001)K260212EnSite™ X EP系统 K253907一次性射频消融电极

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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 K251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF 三叉神经射频探针Neuroone Medical Technologies Corp.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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