LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

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
    Why did this record match?
    Applicant Name (Manufacturer) :

    MLE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
    Ask a Question

    Page 1 of 1