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510(k) Data Aggregation

    K Number
    K971257
    Device Name
    VTU-1 VACUUM ERECTION SYSTEM
    Manufacturer
    MCKENNA & CUNEO
    Date Cleared
    1997-10-03

    (182 days)

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

    VTU-1 VACUUM ERECTION SYSTEM

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

    The VTU-1 is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Vacuum Erection System. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such information would typically be found in the manufacturer's 510(k) submission, which is not provided here.

    Therefore, I cannot provide the requested information. The document explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device...and we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This indicates a substantial equivalence pathway, not a performance study against specific acceptance criteria.

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