Uterine Aspiration Set— 510(k) K251882

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).

Clearance details

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

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