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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Suction, Endometrial (And Accessories)
510(k) Number K251882
Device Name Uterine Aspiration Set
Applicant
Gcmedica Enterprise Ltd.(Wuxi)
18 Xinjin Rd., Xinwu Industrial Zone
Wuxi,  CN 214000
Applicant Contact Adam Jiang
Correspondent
Gcmedica Enterprise Ltd.(Wuxi)
18 Xinjin Rd., Xinwu Industrial Zone
Wuxi,  CN 214000
Correspondent Contact Adam Jiang
Regulation Number884.1175
Classification Product Code
HHK  
Date Received06/20/2025
Decision Date 10/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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