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

    UROLOGICAL LOOP RETRIEVERS

    K Number: K891252 · Decision Mar 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    18
    Applicant Total
    8
    Review Days
    14

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    Basic Information

    Device Name
    UROLOGICAL LOOP RETRIEVERS
    K Number
    K891252
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Northgate Research, Inc.
    Date Received
    March 8, 1989
    Decision Date
    March 22, 1989
    Product Code
    FGO
    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
    FGO Dislodger, Stone, Flexible

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