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

    4-WIRE (CARSON) STONE EXTRACTOR

    K Number: K863081 · Decision Oct 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    51
    Applicant Total
    104
    Review Days
    73

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    Basic Information

    Device Name
    4-WIRE (CARSON) STONE EXTRACTOR
    K Number
    K863081
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cook Urological, Inc.
    Date Received
    August 12, 1986
    Decision Date
    October 24, 1986
    Product Code
    FFL
    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
    FFL Dislodger, Stone, Basket, Ureteral, Metal

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