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510(k) Data Aggregation

    K Number
    K972161
    Device Name
    BOVIE MODEL X15
    Manufacturer
    MAXXIM MEDICAL
    Date Cleared
    1997-06-18

    (9 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

    The BOVIE Mođel X15 Electrosurgical Generator is Indicated for Use in laparoscopic surgical procedures for the cutting and coagulation of human tissue. The BOVIE Model X15 can be used in conjunction with the appropriate accessories and instruments for applications in General Surgery.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the BOVIE Model X15 Electrosurgical Generator. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, or ground truth establishment relevant to an AI/ML medical device.

    Therefore, I cannot fulfill your request based on the provided text. The document is a regulatory approval letter, not a clinical study report.

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