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FDA 510(k)

Rectal Applicator

K号: K251037 · 2025-12-19

决定日期2025-12-19
产品代码JAQ
咨询委员会RA
决定实质等同

器械摘要

Rectal Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron B.V.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251037. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rectal Applicator?

Rectal Applicator is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Nucletron B.V.. The 510(k) number is K251037.

When did Rectal Applicator receive FDA 510(k) clearance?

Rectal Applicator received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251037.

Who is the listed applicant for Rectal Applicator?

FDA 510(k)记录中列出Nucletron B.V.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 Rectal Applicator?

The FDA product code for Rectal Applicator is JAQ.

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Nucletron B.V.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。

相关器械(代码:JAQ)

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

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