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

    STONE BASKET

    K Number: K914505 · Decision Dec 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    51
    Applicant Total
    11
    Review Days
    61

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    Basic Information

    Device Name
    STONE BASKET
    K Number
    K914505
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgitek Medical Engineering Corp.
    Date Received
    October 9, 1991
    Decision Date
    December 9, 1991
    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 Surgitek Medical Engineering Corp.

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    K914503 GRASPING FORCEPS
    K913928 SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT
    K913294 SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
    K910769 SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM
    K910768 SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
    K903127 SURGITEK(R) TURP MONITOR
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