EndoGI S-Path Biliary Stent System

Stents, Drains And Dilators For The Biliary Ducts

Endo GI Medical

The following data is part of a premarket notification filed by Endo Gi Medical with the FDA for Endogi S-path Biliary Stent System.

Pre-market Notification Details

Device IDK202477
510k NumberK202477
Device Name:EndoGI S-Path Biliary Stent System
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant Endo GI Medical 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-28
Decision Date2020-09-24

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