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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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Device Classification Name endoscopic traction device
De Novo Number DEN220006
Device Name ProdiGI
Requester
covidien, llc
3062 bunkerhill lane
santa clara,  CA  95054
Contact liron bar yaakov
Regulation Number876.4410
Classification Product Code
QSW  
Date Received01/14/2022
Decision Date 06/13/2022
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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