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510(k) Data Aggregation

    K Number
    K012620
    Device Name
    SE-200
    Manufacturer
    V.T.S.,INC.
    Date Cleared
    2001-11-09

    (88 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 intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectlle dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called the "SE-200 Vacuum Erection Device." It addresses the regulatory and marketing aspects of the device, including its classification, substantial equivalence to predicate devices, and general controls.

    However, the document does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These details are typically found in the scientific and clinical evidence submitted in a 510(k) application, which is not part of this clearance letter.

    Therefore, I cannot provide the requested information based on the given input.

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