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 K162404
Device Name Express SD Biliary Monorail Premounted Stent System
Applicant
BOSTON SCIENTIFIC CORPORATION
ONE SCIMED PLACE
Maple Grove,  MN  55311 -1566
Applicant Contact Ka Zoua Xiong
Correspondent
BOSTON SCIENTIFIC CORPORATION
ONE SCIMED PLACE
Maple Grove,  MN  55311 -1566
Correspondent Contact Ka Zoua Xiong
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/29/2016
Decision Date 10/12/2016
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
Predetermined Change
Control Plan Authorized		 No
-
-