Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K003102
    Device Name
    PARE ENDOSCOPIC SUTURING SYSTEM
    Date Cleared
    2001-02-27

    (146 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARE SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PARE Endoscopic Suturing System will allow the surgical physician to suture soft tissue when doing gastroenterological procedures using the operating channel of a flexible endoscope.
    Device Description
    The PARÉ Endoscopic Suturing System consists of three concentric tubes and a wire that can fit down the operating channel of a flexible endoscope. Each of the concentric tubes controls a function that is required to do soft tissue suturing at the distal end of the endoscope. These functions include: - A needle, which is used to puncture through the soft tissue 1. - 2. A loop, which is used to capture the free end of the suture. - 3. A holder for the suture that is formed into a pre-tied knot. - A knot pusher, which also performs the function of cutting the suture once the knot is positioned and formed. The device will be loaded only with sutures that have received FDA approval for human use.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1