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

    THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS

    K Number: K011055 · Decision Jun 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    59
    Applicant Total
    11
    Review Days
    61

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    Basic Information

    Device Name
    THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
    K Number
    K011055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Go Medical Industries Pty. , Ltd.
    Date Received
    April 6, 2001
    Decision Date
    June 6, 2001
    Product Code
    FCM
    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
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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    Other Clearances by Go Medical Industries Pty. , Ltd.

    K Number Device Name
    K002803 THE O'NEIL STERILE FIELD URINARY CATHETER KIT
    K000263 GO MEDICAL BALLOON INFUSION SYSTEM
    K910007 SPRINGFUSOR 10R
    K900336 V SET
    K895594 SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
    K890400 MODIFIED URINARY CATHETER INTRODUCER (UCI)
    K891465 OBSTETRIC CUP (MODIFICATION)
    K885283 ASPIRATING AND IRRIGATING CYSTS NEEDLES
    K850758 AMNIGLOVE & AMNICOT
    K840008 O'NEIL OBSTETRIC CUP
    Search all 11 clearances from Go Medical Industries Pty. , Ltd. →