BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    MODIFIED URINARY CATHETER INTRODUCER (UCI)

    K Number: K890400 · Decision Sep 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    11
    Review Days
    231

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    Basic Information

    Device Name
    MODIFIED URINARY CATHETER INTRODUCER (UCI)
    K Number
    K890400
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Go Medical Industries Pty. , Ltd.
    Date Received
    January 24, 1989
    Decision Date
    September 12, 1989
    Product Code
    KOD
    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
    KOD Catheter, Urological

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    K910007 SPRINGFUSOR 10R
    K900336 V SET
    K895594 SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
    K891465 OBSTETRIC CUP (MODIFICATION)
    K885283 ASPIRATING AND IRRIGATING CYSTS NEEDLES
    K850758 AMNIGLOVE & AMNICOT
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