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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K252260
Device Name RELIEEV HSG Catheter (HSG7FA1)
Applicant
Li Medical Corporation , Ltd.
2f., # 43, Zhongxing Rd.,
Xizhi Dist.,  TW 221012
Applicant Contact Jago Chen
Correspondent
Li Medical Corporation , Ltd.
2f., # 43, Zhongxing Rd.,
Xizhi Dist.,  TW 221012
Correspondent Contact Jago Chen
Regulation Number884.4530
Classification Product Code
LKF  
Date Received07/21/2025
Decision Date 11/26/2025
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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