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

    BAG, URINE

    K Number: K902417 · Decision Jul 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    13
    Review Days
    46

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    Basic Information

    Device Name
    BAG, URINE
    K Number
    K902417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gainor Medical Europe, Ltd.
    Date Received
    May 31, 1990
    Decision Date
    July 16, 1990
    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 Gainor Medical Europe, Ltd.

    K Number Device Name
    K926448 I.V. ADMINISTRATION SET
    K931828 CARELET SAFETY LANCET
    K931827 CLEANLET, CLEANLET XL & KIDS
    K922441 SURESEAL BANDAGE
    K913333 I.V. PRIMING SET
    K902422 NEEDLE, ASPIRATION & INJECTION, DISPOSABLE
    K902420 CATHETER, NASAL, OXYGEN
    K902564 NEEDLE, DIALYSIS
    K902426 HEMODIALYSIS SYSTEM AND ACCESSORY
    K902421 STOMACH, GASTRO-ENTEROSTOMY
    Search all 13 clearances from Gainor Medical Europe, Ltd. →