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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K232922
Device Name Pure-Vu EVS System
Applicant
Motus GI Medical Technologies , Ltd.
22 Keren Ha'Yesod St.
Tirat Carmel,  IL 3902638
Applicant Contact Mark Pomeranz
Correspondent
Motus GI Medical Technologies , Ltd.
22 Keren Ha'Yesod St.
Tirat Carmel,  IL 3902638
Correspondent Contact Mark Pomeranz
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
FDS  
Date Received09/19/2023
Decision Date 10/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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