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

    RETRIEVAL BALLOONS

    K Number: K821818 · Decision Sep 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    19
    Review Days
    95

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    Basic Information

    Device Name
    RETRIEVAL BALLOONS
    K Number
    K821818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Endoscopy, Inc.
    Date Received
    June 21, 1982
    Decision Date
    September 24, 1982
    Product Code
    KOD
    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
    KOD Catheter, Urological

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