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

    WELCON HUE-VU URINARY DRAINAGE BAG

    K Number: K971764 · Decision Jul 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    205
    Applicant Total
    8
    Review Days
    77

    Basic Information

    Device Name
    WELCON HUE-VU URINARY DRAINAGE BAG
    K Number
    K971764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WELCON, INC.
    Date Received
    May 13, 1997
    Decision Date
    July 29, 1997
    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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    K830359 STERILE CATHERIZATION PROCEDURE TRAYS
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