BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

    K Number: K112522 · Decision Dec 30, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    5
    Review Days
    121

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    Basic Information

    Device Name
    FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
    K Number
    K112522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Flexible Stenting Solutions, Inc.
    Date Received
    August 31, 2011
    Decision Date
    December 30, 2011
    Product Code
    FGE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by Flexible Stenting Solutions, Inc.

    K Number Device Name
    K121125 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
    K120452 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
    K102519 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
    K081996 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM