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

    FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT

    K Number: K021140 · Decision Jun 28, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT
    K Number
    K021140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fossa Industries, Inc.
    Date Received
    April 9, 2002
    Decision Date
    June 28, 2002
    Product Code
    FAD
    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
    FAD Stent, Ureteral

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    Other Clearances by Fossa Industries, Inc.

    K Number Device Name
    K021602 FOSSA URETERAL STONE SWEEPER