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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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panel: Gastroenterology/Urology Decision Date To: 05/16/2024
 
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Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
Date
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WallFlex Biliary RX Fully Covered Stent BOSTON SCIENTIFIC DEN150040 06/03/2016
vPatch Virility Medical DEN210012 11/23/2021
Vibrant System Vibrant Ltd. DEN210052 08/26/2022
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE UROSURGE, INC. DEN000002 K992069 02/09/2000
UROLIFT SYSTEM NEOTRACT, INC. DEN130023 K130651 09/13/2013
Theranova Dialyzers, Theranova 400 Dialy Baxter Healthcare Corporation DEN190042 08/28/2020
THE 3PM EGG MACHINE 3PM CO., INC. DEN990005 K984637 08/20/1999
Sonablate 450 SonaCare Medical, LLC. DEN150011 10/09/2015
Sensor Monitored Alimentary Restriction SCIENTIFIC INTAKE DEN150033 09/26/2016
SEM Scanner (Model 200) Bruin Biometrics, LLC DEN170021 12/20/2018
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