FDA 510(k)

Uterine Aspiration Set

K-Number: K251882 · 2025-10-16

Decision Date2025-10-16

Product CodeHHK

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Uterine Aspiration Set?

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

When was Uterine Aspiration Set approved by the FDA?

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

What company makes Uterine Aspiration Set?

Uterine Aspiration Set is manufactured by Gcmedica Enterprise Ltd.(Wuxi).

What is the FDA product code for Uterine Aspiration Set?

The FDA product code for Uterine Aspiration Set is HHK.

Related Clinical Trials

NCT07396181 Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans RECRUITING

Other Devices by Gcmedica Enterprise Ltd.(Wuxi)

K182819Decanting Device

Related Devices (Code: HHK)

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Official Source

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