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510(k) Data Aggregation

    K Number
    K220505
    Device Name
    ATTIVA
    Manufacturer
    Italian Engineering srl
    Date Cleared
    2023-02-09

    (352 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ATTIVA is a Radiofrequency (RF) System (generator, electrodes/handpieces and accessories) indicated for treatments based on the emission of electromagnetic waves that lead to a rise of internal temperature of tissues involved in the treatment for electrocoagulation and hemostasis. ATTIVA device can be used on adult patients only.

    Device Description

    ATTIVA is a Radiofrequency (RF) System (generator, electrodes/handpieces and accessories)

    AI/ML Overview

    I am sorry, but the provided text is a standard FDA 510(k) clearance letter and an "Indications for Use" statement. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for a device. Therefore, I cannot fulfill your request based on the given input.

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