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

    DUTHOY STONE BASKET

    K Number: K861469 · Decision May 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    51
    Applicant Total
    42
    Review Days
    23

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    Basic Information

    Device Name
    DUTHOY STONE BASKET
    K Number
    K861469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Lake Region Mfg., Inc.
    Date Received
    April 22, 1986
    Decision Date
    May 15, 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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    Other Clearances by Lake Region Mfg., Inc.

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    K080144 MANDREL GUIDEWIRES OR M-WIRES
    K073655 PEGASUS STEERABLE (PTCA) GUIDEWIRE
    K060454 TITAN GUIDEWIRE
    K052347 TITAN STEERABLE (PTCA) GUIDEWIRE
    K042338 CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
    K041624 PTCA STEERABLE HYDROPHILIC GUIDEWIRE
    K040825 LAKE REGION HYDROPHILIC GUIDEWIRE
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