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 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.

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. 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.

Other records listing Gcmedica Enterprise Ltd.(Wuxi) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182819Decanting Device

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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.