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

    HMT ALEXCOPE

    K Number: K941013 · Decision Feb 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    3
    Review Days
    343

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    Basic Information

    Device Name
    HMT ALEXCOPE
    K Number
    K941013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Servicetrends, Inc.
    Date Received
    March 3, 1994
    Decision Date
    February 9, 1995
    Product Code
    FGB
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

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    Other Clearances by Servicetrends, Inc.

    K Number Device Name
    K942155 HMT ENDOSCREEN, MODEL ESC 501
    K940461 ALEXANTRIPTOR