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

    AM CATH ESWL STENT

    K Number: K871291 · Decision Apr 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    AM CATH ESWL STENT
    K Number
    K871291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Inter-Med Corp.
    Date Received
    March 31, 1987
    Decision Date
    April 30, 1987
    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 Inter-Med Corp.

    K Number Device Name
    K864669 AM CATH ESWL STENT
    K851922 URETERAL STONE DISLODGER
    K833058 GEN. PURPOSE INSTRUMENT TRAYS &