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

    BAG, LEG, URINE COLLECTING DEVICE

    K Number: K760069 · Decision Oct 20, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    24
    Review Days
    126

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    Basic Information

    Device Name
    BAG, LEG, URINE COLLECTING DEVICE
    K Number
    K760069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Pharmaseal Div., Baxter Healthcare Corp.
    Date Received
    June 16, 1976
    Decision Date
    October 20, 1976
    Product Code
    KNX
    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
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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