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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 K172846
Device Name Uterine Manipulator
Applicant
Beijing Hangtian Kadi Technology R&D Institute
Rm.301-11, Third Floor, Bldg. #13,
#15 Jing Sheng Nan Er St.
Beijing,  CN 101102
Applicant Contact Liying Zhang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number884.4530
Classification Product Code
LKF  
Date Received09/19/2017
Decision Date 06/26/2018
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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