BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe

    K Number: K232943 · Decision May 31, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    11
    Applicant Total
    52
    Review Days
    254

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    Basic Information

    Device Name
    Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
    K Number
    K232943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Medical Asd, Inc.
    Date Received
    September 20, 2023
    Decision Date
    May 31, 2024
    Product Code
    QNQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QNQ Low Dead Space Piston Syringe

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