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510(k) Data Aggregation

    K Number
    K974196
    Device Name
    MEGAVAC SYSTEM
    Manufacturer
    BARRY J. KAPLAN, INC.
    Date Cleared
    1998-05-12

    (186 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mega Vac System creates and maintains penile erection in impotent men.

    Device Description

    External Penile Rigidity Device including Vacuum Pump and Constriction Rings

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) clearance letter from the FDA for a device called "MegaVac System" and an "Indications for Use" statement. It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

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