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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culdoscope (And Accessories)
510(k) Number K143650
Device Name CooperSurgical Advincula Delineator Uterine Manipulator
Applicant
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact James Keller
Correspondent
Orchid Design
80 Shelton Technology Center
Shelton,  CT  06484
Correspondent Contact Tim M Lohnes
Regulation Number884.1640
Classification Product Code
HEW  
Date Received12/23/2014
Decision Date 07/21/2015
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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