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

    COVER-ALL MALE INCONTINENCE DEVICE

    K Number: K801629 · Decision Aug 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    6
    Review Days
    28

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    Basic Information

    Device Name
    COVER-ALL MALE INCONTINENCE DEVICE
    K Number
    K801629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    The Urology Group
    Date Received
    July 15, 1980
    Decision Date
    August 12, 1980
    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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    Other Clearances by The Urology Group

    K Number Device Name
    K831703 COVERUPS
    K831489 SURGICAL TUBE HOLDER
    K810739 SUCTION WOUND DRAINAGE DEVICE
    K810788 SURGICAL TUBE HOLDER
    K810787 UROLOGIC TUBE HOLDER