Uterine Aspiration Set— 510(k) K251882

Name: FDA 510(k) clearance K251882
Creator: U.S. Food and Drug Administration
Published: 2025-10-16

Substantially Equivalent

Gcmedica Enterprise Ltd.(Wuxi)

FDA 510(k) clearance K251882 for Uterine Aspiration Set, Substantially Equivalent on 2025-10-16. Applicant: Gcmedica Enterprise Ltd.(Wuxi). Device class: 2.

Clearance details

Applicant: Gcmedica Enterprise Ltd.(Wuxi)
Product code: Code HHK
Device class: Class 2
Regulation: 21 CFR 884.1175
Advisory panel: Obstetrics/Gynecology
Date received: 2025-06-20
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, CN

Download summary PDF View on FDA.gov ↗

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