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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 K223064
Device Name ALLY II Uterine Positioning System™ (UPS)
Applicant
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact Yin Huang
Correspondent
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Correspondent Contact Yin Huang
Regulation Number884.4530
Classification Product Code
LKF  
Date Received09/30/2022
Decision Date 10/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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