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510(k) Data Aggregation

    K Number
    K162201
    Device Name
    Desara TV, Desara Blue TV
    Manufacturer
    CALDERA MEDICAL, INC.
    Date Cleared
    2017-01-11

    (159 days)

    Product Code
    OTN
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Desara TV, Desara Blue TV

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

    Desara® TV and Desara® Blue TV are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding surgical mesh products (Desara TV and Desara Blue TV). It discusses regulatory aspects, general controls, and indications for use.

    However, the document DOES NOT contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory approval letter and does not delve into the technical validation of the device's performance.

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