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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 K201086
Device Name Advincula Delineator Uterine Manipulator
Applicant
CooperSurgical, Inc.
95 Corporate Drive
Trumbull,  CT  06611
Applicant Contact Kyle Hooper
Correspondent
CooperSurgical, Inc.
95 Corporate Drive
Trumbull,  CT  06611
Correspondent Contact Kyle Hooper
Regulation Number884.1640
Classification Product Code
HEW  
Date Received04/23/2020
Decision Date 05/21/2020
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
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