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

    OBSTETRIC CUP (MODIFICATION)

    K Number: K891465 · Decision May 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    29
    Applicant Total
    11
    Review Days
    57

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    Basic Information

    Device Name
    OBSTETRIC CUP (MODIFICATION)
    K Number
    K891465
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4340
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Go Medical Industries Pty. , Ltd.
    Date Received
    March 15, 1989
    Decision Date
    May 11, 1989
    Product Code
    HDB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HDB Extractor, Vacuum, Fetal

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    Other Clearances by Go Medical Industries Pty. , Ltd.

    K Number Device Name
    K011055 THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
    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)
    K885283 ASPIRATING AND IRRIGATING CYSTS NEEDLES
    K850758 AMNIGLOVE & AMNICOT
    K840008 O'NEIL OBSTETRIC CUP
    Search all 11 clearances from Go Medical Industries Pty. , Ltd. →