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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: 05/02/2024
 
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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NaviCam ProScan Ankon Technologies Co., Ltd DEN230027 12/12/2023
DuraGraft Marizyme, Inc. DEN230002 10/04/2023
AXIOS Stent and Electrocautery-Enhanced Boston Scientific Corporation DEN230019 08/18/2023
Revi System BlueWind Medical Ltd. DEN220073 08/16/2023
Eroxon Futura Medical Developments Limited DEN220078 06/09/2023
Pill Sense System EnteraSense Ltd. DEN220065 02/24/2023
Vibrant System Vibrant Ltd. DEN210052 08/26/2022
AccuMeasure System RQMIS Inc. DEN210032 07/26/2022
APOLLO ESG System, APOLLO ESG SX System, Apollo Endosurgery, Inc. DEN210045 07/12/2022
ProdiGI Covidien LLC DEN220006 06/13/2022
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