FDA 510(k)

RELIEEV 宫腔操纵注射器（CUMI 5.0）

K号: K240364 · 2024-10-16

决定日期2024-10-16

产品代码LKF

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决定实质等同

器械摘要

RELIEEV Uterine Manipulator Injector (CUMI 5.0) is the device name listed in this FDA 510(k) record. The listed applicant is Li Medical Corporation , Ltd.. It received FDA 510(k) clearance on 2024-10-16 under 510(k) number K240364. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RELIEEV Uterine Manipulator Injector (CUMI 5.0)?

RELIEEV Uterine Manipulator Injector (CUMI 5.0) is a medical device that received FDA 510(k) clearance on 2024-10-16. The listed applicant is Li Medical Corporation , Ltd.. The 510(k) number is K240364.

When did RELIEEV Uterine Manipulator Injector (CUMI 5.0) receive FDA 510(k) clearance?

RELIEEV Uterine Manipulator Injector (CUMI 5.0) received FDA 510(k) clearance on 2024-10-16, under 510(k) number K240364.

Who is the listed applicant for RELIEEV Uterine Manipulator Injector (CUMI 5.0)?

The FDA 510(k) record lists Li Medical Corporation , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RELIEEV Uterine Manipulator Injector (CUMI 5.0)?

The FDA product code for RELIEEV Uterine Manipulator Injector (CUMI 5.0) is LKF.

列明Li Medical Corporation , Ltd.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。

K252260RELIEEV HSG 球囊导管 (HSG7FA1)K240434RELIEEV 吸引器刮匙（柔性 3.0/标准 3.6）

官方来源

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