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 K121125
Device Name FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
Applicant
FLEXIBLE STENTING SOLUTIONS, INC.
23 Christopher Way, Suite 103
Eatontown,  NJ  07724
Applicant Contact JOSEPH C GRIFFIN III
Correspondent
FLEXIBLE STENTING SOLUTIONS, INC.
23 Christopher Way, Suite 103
Eatontown,  NJ  07724
Correspondent Contact JOSEPH C GRIFFIN III
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/13/2012
Decision Date 07/06/2012
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-