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 Prosthesis, Esophageal
510(k) Number K162717
Device Name Evolution Esophageal Stent System – Partially Covered
Applicant
Cook Ireland Ltd.
O'Halloran Road, National Technology Park
Limerick,  IE
Applicant Contact Jane Kennedy
Correspondent
Cook Ireland Ltd.
O'Halloran Road, National Technology Park
Limerick,  IE
Correspondent Contact Jane Kennedy
Regulation Number878.3610
Classification Product Code
ESW  
Date Received09/29/2016
Decision Date 12/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-