FDA 510(k)

子宫吸宫套装

K号: K251882 · 2025-10-16

决定日期2025-10-16

产品代码HHK

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决定实质等同

器械摘要

Uterine Aspiration Set is the device name listed in this FDA 510(k) record. The listed applicant is Gcmedica Enterprise Ltd.(Wuxi). It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K251882. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Uterine Aspiration Set?

Uterine Aspiration Set is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Gcmedica Enterprise Ltd.(Wuxi). The 510(k) number is K251882.

When did Uterine Aspiration Set receive FDA 510(k) clearance?

Uterine Aspiration Set received FDA 510(k) clearance on 2025-10-16, under 510(k) number K251882.

Who is the listed applicant for Uterine Aspiration Set?

The FDA 510(k) record lists Gcmedica Enterprise Ltd.(Wuxi) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uterine Aspiration Set?

The FDA product code for Uterine Aspiration Set is HHK.

列明Gcmedica Enterprise Ltd.(Wuxi)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。

K182819分装设备

官方来源

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