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510(k) Data Aggregation

    K Number
    K981172
    Device Name
    LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES
    Manufacturer
    BYRON MEDICAL
    Date Cleared
    1998-06-30

    (90 days)

    Product Code
    QPB,MUU
    Regulation Number
    878.5040
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K861878
    Why did this record match?
    Device Name :

    LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES

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

    The Aspiration and Infusion Cannulae and Needles indications for use are for Aesthetic Body Contouring.

    Device Description

    The principles of operation and technology incorporated in the Cannulae and Needles are equivalent to fluid, soft tissue, and exudate removal and infusion instruments generally used for aspiration and infusion, utilizing a hollow Stainless Steal tube with multiple tip, handle and attachment connectors that are in a reusable and disposable configuration.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification for Lipoplasty/Liposuction Aspiration and Tumescent Infusion Cannulae and Needles, indicating that the device is substantially equivalent to a previously marketed device. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study's results based on the provided text.

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