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

    MODIFICATION TO FOSSA URETERAL STONE SWEEPER

    K Number: K031292 · Decision May 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    3
    Review Days
    29

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    Basic Information

    Device Name
    MODIFICATION TO FOSSA URETERAL STONE SWEEPER
    K Number
    K031292
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fossa Medical, Inc.
    Date Received
    April 23, 2003
    Decision Date
    May 22, 2003
    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 Medical, Inc.

    K Number Device Name
    K072293 FOSSA URETERAL OPEN STENTS
    K033368 FOSSA URETERAL OPEN LUMEN STENT