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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, biliary, diagnostic
510(K) Number K121125
Model FLX-DDLLL-BX
Device Name FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
Applicant
FLEXIBLE STENTING SOLUTIONS, INC.
23 christopher way, suite 103
eatontown,  NJ  07724
Contact joseph c griffin iii
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/13/2012
Decision Date 07/06/2012
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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