EndoGI Biliary Stent System

Stents, Drains And Dilators For The Biliary Ducts

EndoGI Medical, Ltd.

The following data is part of a premarket notification filed by Endogi Medical, Ltd. with the FDA for Endogi Biliary Stent System.

Pre-market Notification Details

Device IDK193600
510k NumberK193600
Device Name:EndoGI Biliary Stent System
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant EndoGI Medical, Ltd. 13 Wadi El Hadj Nazareth,  IL
ContactOmri Naveh
CorrespondentBosmat Friedman
ProMedoss, Inc 3521 Hatwynn Rd. Charlotte,  NC  28269
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-06-26

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