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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: 05/17/2024
 
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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
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AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC DEN130007 K123250 12/18/2013
vPatch Virility Medical DEN210012 11/23/2021
Vibrant System Vibrant Ltd. DEN210052 08/26/2022
INFLOW INTRAURETHRAL VALVE-PUMP VESIFLO, INC. DEN130044 10/14/2014
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE UROSURGE, INC. DEN000002 K992069 02/09/2000
Sonablate 450 SonaCare Medical, LLC. DEN150011 10/09/2015
Sensor Monitored Alimentary Restriction SCIENTIFIC INTAKE DEN150033 09/26/2016
AccuMeasure System RQMIS Inc. DEN210032 07/26/2022
ECLIPSE SYSTEM PELVALON DEN140020 02/12/2015
UROLIFT SYSTEM NEOTRACT, INC. DEN130023 K130651 09/13/2013
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