Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K193600
Device Name EndoGI 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 Received12/23/2019
Decision Date 06/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-