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510(k) Data Aggregation

    K Number
    K213483
    Device Name
    SnapLoc Wire Lock
    Manufacturer
    Wilson Cook Medical
    Date Cleared
    2022-04-26

    (179 days)

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

    Wilson Cook Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is an accessory to be used with endoscopic biliary and pancreatic devices to lock the wire guide(s) in place and to prevent reflux of bodily fluids during ERCP
    Device Description
    The SnapLoc Wire Lock device is an accessory that is clipped onto the outside of a Duodenoscope during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. Its purpose is to help control the wire guides during a procedure, to enable ERCP devices (catheters, baskets, balloons, stents, etc) to pass through the device and to prevent the backflow of bodily fluids during procedures. The SnapLoc wire lock contains features to aid in wire control. The wire is locked into place by simply sliding the wire into one of the locking notches located on the left and right sides of the wire is unlocked by lifting the wire out of the wire locking notch. For control, the proximal end of the wire can be secured by inserting it into one of the docking channels. A silicone seal located between the molded components helps reduce leakage from the duodenoscope. For ease of connection, the wire lock attaches to the duodenoscope by sliding laterally onto the port until secure. The SnapLoc will be sold in three sizes to be compatible with the most commonly used endoscopes from Olympus. Fuji, and Pentax.
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