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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 K240364
Device Name RELIEEV Uterine Manipulator Injector (CUMI 5.0)
Applicant
Li Medical Corporation , Ltd.
2f., # 43, Zhongxing Rd.,
Xizhi Dist.,  TW 221012
Applicant Contact Chen Jago
Correspondent
Li Medical Corporation , Ltd.
2f., # 43, Zhongxing Rd.,
Xizhi Dist.,  TW 221012
Correspondent Contact Chen Jago
Regulation Number884.4530
Classification Product Code
LKF  
Date Received02/06/2024
Decision Date 10/16/2024
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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