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510(k) Data Aggregation

    K Number
    K974479
    Device Name
    SILIMED VAGINAL STENT
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-08-05

    (252 days)

    Product Code
    KXP
    Regulation Number
    884.3900
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Silimed Vaginal Stent is designed to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.

    The surgeon is responsible for proper choice of size to meet the clinical and aesthetic needs of each case.

    Device Description

    Silimed Vaginal Stent

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Silimed Vaginal Stent) and its indications for use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. Therefore, I cannot fulfill your request based on the given input.

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