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510(k) Data Aggregation

    K Number
    K202542
    Device Name
    Allura Vaginal Stent
    Manufacturer
    PMT Corporation
    Date Cleared
    2020-09-30

    (28 days)

    Product Code
    KXP
    Regulation Number
    884.3900
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Allura Vaginal Stent

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

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

    Device Description

    Not Found

    AI/ML Overview

    I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text is a 510(k) clearance letter for the Allura™ Vaginal Stent and does not contain information about acceptance criteria or supporting studies. It merely states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

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