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510(k) Data Aggregation

    K Number
    K050418
    Device Name
    TISSUE FIXATION SYSTEM
    Manufacturer
    TFS MANUFACTURING PTY LTD
    Date Cleared
    2005-05-16

    (87 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TFS Device is intended to be used in females to position a polypropylene mesh tape for the treatment of Genuine Stress Urinary Incontinence, mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.

    Device Description

    Tissue Fixation System (TFS Device)

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, data provenance, ground truth establishment, or expert involvement for a medical device. The document is an FDA 510(k) clearance letter for a "Tissue Fixation System (TFS Device)," acknowledging its substantial equivalence to legally marketed predicate devices for specific indications for use. It outlines regulatory requirements but does not contain the detailed study information you've requested.

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