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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K232596
Device Name EndoGI S-Path Biliary Stent System
Applicant
EndoGI Medical, Ltd.
13 Wadi El Hadj
Nazareth,  IL
Applicant Contact Omri Naveh
Correspondent
ProMedoss, Inc
3521 Hatwynn Rd.
Charlotte,  NC  28269
Correspondent Contact Bosmat Friedman
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/25/2023
Decision Date 09/27/2023
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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