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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 K161065
Device Name ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
Surgitools Pty Ltd.
231 Timberlane Dr.
Woodvale,  AU 6026
Applicant Contact Jai Singh
Emergo Global Consulting, LLC
816 Congress Avenue, Suite 1400
Austin,  TX  78701
Correspondent Contact Elizabeth Pugh
Regulation Number884.1640
Classification Product Code
Date Received04/15/2016
Decision Date 10/27/2016
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