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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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11 to 20 of 40 results
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
sort by DeNovo number [0-9]
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510(k)
Number
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Decision
Date
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sort by decision date [9-0]
vPatch Virility Medical DEN210012 11/23/2021
GI Genius Cosmo Artificial Intelligence - AI, LTD DEN200055 04/09/2021
EndoRotor Device Interscope, Inc DEN200016 12/23/2020
Parallel Mahana Therapeutics, Inc. DEN200029 11/25/2020
Theranova Dialyzers, Theranova 400 Dialy Baxter Healthcare Corporation DEN190042 08/28/2020
NaviCam Capsule Endoscope System with Na AnX Robotica, Inc. DEN190037 05/22/2020
CARPEDIEM System Bellco srl (now part of Medtronic, Inc) DEN180055 04/29/2020
iTind System Medi-Tate Ltd. DEN190020 02/25/2020
Mucosal Integrity Conductivity (MI) Test Diversatek Healthcare Inc. DEN180067 12/23/2019
EchoTip Insight Portosystemic Pressure G Cook Ireland Ltd. DEN180062 11/20/2019
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