FDA 510(k)

IMAGE1 (TC400US)；X-to-4U 适配器 (TC040)

K号: K253972 · 2026-02-12

决定日期2026-02-12

产品代码OWN

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决定实质等同

器械摘要

IMAGE1 (TC400US); X-to-4U Adapter (TC040) 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 2026-02-12 under 510(k) number K253972. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IMAGE1 (TC400US); X-to-4U Adapter (TC040)?

IMAGE1 (TC400US); X-to-4U Adapter (TC040) is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K253972.

When did IMAGE1 (TC400US); X-to-4U Adapter (TC040) receive FDA 510(k) clearance?

IMAGE1 (TC400US); X-to-4U Adapter (TC040) received FDA 510(k) clearance on 2026-02-12, under 510(k) number K253972.

Who is the listed applicant for IMAGE1 (TC400US); X-to-4U Adapter (TC040)?

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 IMAGE1 (TC400US); X-to-4U Adapter (TC040)?

The FDA product code for IMAGE1 (TC400US); X-to-4U Adapter (TC040) is OWN.

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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