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510(k) Data Aggregation

    K Number
    K003115
    Device Name
    ACTIS ADJUSTABLE CONSTRICTION LOOP
    Manufacturer
    VIVUS, INC.
    Date Cleared
    2000-12-19

    (78 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K962915
    Device Name
    ACTIS (VENOUS FLOW CONTROLLER)
    Manufacturer
    VIVUS, INC.
    Date Cleared
    1996-12-10

    (137 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVUS, INC.

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

    The ACTIS® (Venous Flow Controller) device is an erection enhancement device that is designed to slow venous outflow from the penis and thus aid in the normal erection process.

    Device Description

    It is a linear elastic tube with an O ring and ball locking unit that allows ease of adjustment to increase or decrease tension. Placement is around the base of the penis.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and study details as per your request. The document is a 510(k) summary for a medical device (ACTIS® Venous Flow Controller) and primarily focuses on its description, intended use, and substantial equivalence to a predicate device. It does not include performance data, study design details, or acceptance criteria in the format you've specified.

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