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

    Quiver Laparoscopic Extendable

    K Number: K153472 · Decision Jun 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    30
    Applicant Total
    5
    Review Days
    204

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    Basic Information

    Device Name
    Quiver Laparoscopic Extendable
    K Number
    K153472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Itl Corporation Pty, Ltd.
    Date Received
    December 2, 2015
    Decision Date
    June 23, 2016
    Product Code
    HAM
    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
    HAM Apparatus, Electrosurgical

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