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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
    Why did this record match?
    Product Code :

    KXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    K Number
    K983045
    Device Name
    AMIELLE
    Manufacturer
    Owen Mumford USA, Inc.
    Date Cleared
    1998-11-25

    (85 days)

    Product Code
    KXP
    Regulation Number
    884.3900
    Why did this record match?
    Product Code :

    KXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to treat women suffering from vaginismus and dyspareunia. VAGINISMUS is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. DYSPAREUNIA is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device comes in varying sizes, the most appropriate is then selected by the physician for use by the patient and the patient's partner as an assistant if appropriate. It is used as a tool to DILATE the vagina in controlled stages.
    Device Description
    Four smooth, high polished finish, hollow, penile shaped cones which are graduated in size and length. Owen Mumfords Amielle is visually and mechanically similar to that of Young's Vaginal Dilator to which substantially equivalence is claimed.
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    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
    Why did this record match?
    Product Code :

    KXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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