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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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21 to 30 of 40 results
panel: Gastroenterology/Urology Decision Date To: 06/01/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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NaviCam Capsule Endoscope System with Na AnX Robotica, Inc. DEN190037 05/22/2020
NaviCam ProScan Ankon Technologies Co., Ltd DEN230027 12/12/2023
Parallel Mahana Therapeutics, Inc. DEN200029 11/25/2020
Pill Sense System EnteraSense Ltd. DEN220065 02/24/2023
Plenity Gelesis, Inc. DEN180060 04/12/2019
ProdiGI Covidien LLC DEN220006 06/13/2022
PROLONG ERGON MEDICAL LTD. DEN130047 03/20/2015
PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC DEN100016 K093579 04/27/2012
RELIZORB ALCRESTA, INC. DEN150001 11/20/2015
Revi System BlueWind Medical Ltd. DEN220073 08/16/2023
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