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510(k) Data Aggregation

    K Number
    K021834
    Device Name
    SUTURE FIXATION DEVICE; MESH FIXATION DEVICE
    Manufacturer
    MLE, INC.
    Date Cleared
    2002-08-28

    (85 days)

    Product Code
    GAW
    Regulation Number
    878.5010
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MLE, INC.

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

    For use in procedures requiring fixation of suspending sutures and/or surgical mesh to soft tissue. This includes but is not limited to pubourethral support and bladder neck support procedures for the treatment of female stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

    Device Description

    The system includes a surgical stainless stcel retention anchor with attached polypropylene suture, and a delivery device for placement of the implant. The system may be supplied with legally marketed surgical mesh marketed for use in treating female stress urinary incontinence.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for a Suture/Mesh Fixation System (K021384/K021834). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    The 510(k) process for this type of device (Class II surgical suture) typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the same way a novel high-risk device or an AI/ML powered device might.

    Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory classification, intended use, and the claim of substantial equivalence.

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