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510(k) Data Aggregation

    K Number
    K172666
    Device Name
    CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
    Manufacturer
    Date Cleared
    2017-12-01

    (87 days)

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

    SutureEase, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is intended to pass suture through soft tissue lavers (fascia, muscle and perioneum) of a trocar wound at the end of laparoscopic surgery. It is to be used only by surgeons trained in endoscopic/laparoscopic surgery.
    Device Description
    The CrossBow Fascial Closure System is a set of single-use instruments primarily intended for the use of closing soft tissue layers (fascia, muscle and peritoneum) of a trocar wound following laparoscopic surgery. The CrossBow Fascial Closure System has two basic components: (1) a suture passer component used to pass suture through the abdominal wall, and (2) a guide used to repeatedly direct the needle through the abdominal wall using visual markers to reference the needle puncture location off the inner wall of the abdomen. The guide has two deployable snare loops used to secure and retrieve the free ends of suture passed by the suture passer. The device also has an accessory adaptor to accommodate larger size port defects.
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