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FDA 510(k)

KARL STORZ单极电切镜带高频电缆

K号: K232486 · 2024-05-07

决定日期2024-05-07
产品代码FJL
咨询委员会GU 请注意,由于您只提供了“GU”这个词,我无法提供完整的翻译。如果您能提供完整的句子或段落,我将能够为您提供准确的翻译。
决定实质等同

器械摘要

KARL STORZ Monopolar Resectoscopes with HF Cable is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K232486. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KARL STORZ Monopolar Resectoscopes with HF Cable?

KARL STORZ Monopolar Resectoscopes with HF Cable is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K232486.

When did KARL STORZ Monopolar Resectoscopes with HF Cable receive FDA 510(k) clearance?

KARL STORZ Monopolar Resectoscopes with HF Cable received FDA 510(k) clearance on 2024-05-07, under 510(k) number K232486.

Who is the listed applicant for KARL STORZ Monopolar Resectoscopes with HF Cable?

FDA 510(k)记录中列出Karl Storz SE & CO. KG为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for KARL STORZ Monopolar Resectoscopes with HF Cable?

The FDA product code for KARL STORZ Monopolar Resectoscopes with HF Cable is FJL.

相关临床试验

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。

列明Karl Storz SE & CO. KG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:FJL)

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。

官方来源

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