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510(k) Data Aggregation

    K Number
    K012042
    Device Name
    KINETIC CANNULA
    Manufacturer
    RELIANCE MEDICAL CORP.
    Date Cleared
    2001-09-20

    (83 days)

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

    KINETIC CANNULA

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

    The Reliance Medical Kinetic Cannula indications for use are the removal of tissue or fluid from the body during general surgical the removal of tissue of fliala lipoplasty for the purpose of aesthetic body contouring.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot extract any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Kinetic Cannula" and primarily focuses on regulatory approval and substantial equivalence to a predicate device. It does not contain details about performance studies, acceptance criteria, sample sizes, or ground truth establishment.

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