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510(k) Data Aggregation

    K Number
    K012042
    Device Name
    KINETIC CANNULA
    Date Cleared
    2001-09-20

    (83 days)

    Product Code
    Regulation Number
    878.5040
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    RELIANCE MEDICAL CORP.

    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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    K Number
    K012044
    Date Cleared
    2001-08-28

    (60 days)

    Product Code
    Regulation Number
    880.5725
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    RELIANCE MEDICAL CORP.

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

    The Reliance Medical Bi-Phasic Infiltrator indication for use is: General surgical fluid irrigation and infiltration.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study design, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a device called "Bi-Phasic Infiltrator," indicating it is substantially equivalent to a legally marketed predicate device for general surgical fluid irrigation and infiltration. It does not contain the detailed study information you are requesting.

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