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510(k) Data Aggregation

    K Number
    K983015
    Device Name
    VIRILIS PENILE PROSTHESIS
    Manufacturer
    SPECIALTY SURGICAL PRODUCTS, INC.
    Date Cleared
    1999-02-05

    (161 days)

    Product Code
    FTQ
    Regulation Number
    876.3630
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    FTQ

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

    The Virilis Penile Prostheses are intended for implantation into the corpora cavernosa of the penis in patients who are diagnosed as having erectile dysfunction. The prosthesis is implanted to provid adequate penile rigidity for vaginal penetration.

    Device Description

    Virilis Penile Prostheses

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter and an "Indications For Use" statement. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a study that proves the device meets acceptance criteria.

    The document states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This process confirms that the new device is as safe and effective as a legally marketed device; it does not involve a study to demonstrate performance against specific acceptance criteria in the way a clinical trial or performance study would.

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

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