BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇺 Australia

    SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE

    K Number: K895594 · Decision Oct 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    47
    Applicant Total
    11
    Review Days
    21

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
    K Number
    K895594
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Go Medical Industries Pty. , Ltd.
    Date Received
    September 15, 1989
    Decision Date
    October 6, 1989
    Product Code
    GDM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GDM Needle, Aspiration And Injection, Reusable

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GDM), ordered by most recent decision date.

    MARROWMINER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BIOACCESS MARROW HARVEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ILIAC CREST BONE MARROW ASPIRATION NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BIOACCESS MARROW HARVEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ENDO-NEEDLE INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    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
    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. →