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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)
Number
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Decision
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AccuMeasure System RQMIS Inc. DEN210032 07/26/2022
APOLLO ESG System, APOLLO ESG SX System, Apollo Endosurgery, Inc. DEN210045 07/12/2022
AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC DEN130007 K123250 12/18/2013
AXIOS Stent and Electrocautery-Enhanced Boston Scientific Corporation DEN230019 08/18/2023
CARPEDIEM System Bellco srl (now part of Medtronic, Inc) DEN180055 04/29/2020
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. DEN000008 K001447 02/16/2001
DuraGraft Marizyme, Inc. DEN230002 10/04/2023
EchoTip Insight Portosystemic Pressure G Cook Ireland Ltd. DEN180062 11/20/2019
ECLIPSE SYSTEM PELVALON DEN140020 02/12/2015
Embosphere Microspheres Biosphere Medical S.A. DEN160040 06/21/2017
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