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510(k) Data Aggregation

    K Number
    K081039
    Device Name
    LIPO CANNULA
    Manufacturer
    MILLENNIUM MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2008-07-10

    (90 days)

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

    LIPO CANNULA

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

    Liposuction cannulas are indicated for aesthetic body countering and tissue aspiration

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Lipo Cannula." It concerns the regulatory classification and substantial equivalence of the device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot provide the requested information based on the provided text. The letter primarily addresses administrative changes to the device's product code and confirms its substantial equivalence to previously marketed devices.

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