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510(k) Data Aggregation

    K Number
    K090419
    Device Name
    SILS STITCH ENDOSCOPIC SUTURING DEVICE
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Date Cleared
    2009-03-09

    (19 days)

    Product Code
    OCW
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K072814,K082619,K082659
    Why did this record match?
    Device Name :

    SILS STITCH ENDOSCOPIC SUTURING DEVICE

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

    The SILS™ Stitch 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues

    Device Description

    SILSTM Stitch is an endoscopic suturing device that contains two jaws at its distal end, with opposing handles and a toggle lever at its proximal end. The device holds and passes a needled suture between the two jaws. The suture needle is passed from one jaw to another by squeezing the opposing handles and secured in each jaw by activating the toggle lever.

    AI/ML Overview

    The provided text states that "No additional in-vitro or in-vivo testing has been performed in support of the intended use of this device." This means there is no performance data or study described. Therefore, the requested sections cannot be filled.

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