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FDA 510(k)

RELIEEV Uterine Manipulator Injector (CUMI 5.0)

K-Number: K240364 · 2024-10-16

ApplicantLi Medical Corporation , Ltd.
Decision Date2024-10-16
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Li Medical Corporation , Ltd.. The 510(k) number is K240364.

When was RELIEEV Uterine Manipulator Injector (CUMI 5.0) approved by the FDA?

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

What company makes RELIEEV Uterine Manipulator Injector (CUMI 5.0)?

RELIEEV Uterine Manipulator Injector (CUMI 5.0) is manufactured by Li Medical Corporation , Ltd..

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.

Related Clinical Trials

NCT05687084 Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial RECRUITING

Other Devices by Li Medical Corporation , Ltd.

K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) K252260RELIEEV HSG Catheter (HSG7FA1)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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