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510(k) Data Aggregation

    K Number
    K032528
    Device Name
    BD ECLIPSE BIFURCATED NEEDLE
    Manufacturer
    BECTON DICKINSON & CO.
    Date Cleared
    2003-09-09

    (25 days)

    Product Code
    SCL,LDH
    Regulation Number
    880.5570
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BD ECLIPSE BIFURCATED NEEDLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BD Eclipse™ Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
    The BD Eclipse™ Bifurcated Needle contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided documents, there is no information about acceptance criteria or a study that proves the device meets any specific acceptance criteria.

    The documents are FDA letters regarding a 510(k) premarket notification for the "BD Eclipse Bifurcated Needle." These letters confirm the device's substantial equivalence to legally marketed predicate devices and reclassify its product code. They do not contain details about performance studies, acceptance criteria, or specific performance metrics.

    Therefore, I cannot provide the requested information.

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