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510(k) Data Aggregation

    K Number
    K152082
    Device Name
    Vesocclude Polymer Ligating Clip
    Date Cleared
    2016-02-26

    (214 days)

    Product Code
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vesocclude Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended Use: The Vesocclude Polymer Ligation Clips are in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
    Device Description
    The Vesocclude™ ligating clips are non-absorbable, nonactive implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use.
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    K Number
    K091060
    Device Name
    VESOCCLUDE LIGATING CLIP
    Date Cleared
    2009-09-23

    (162 days)

    Product Code
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    VESOCCLUDE MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Vesocclude ligating clips are intended for use in procedures involving vessels or anatomic structures for which the user determines ligating clips are the best choice. Users should select the size and amount of the clips based on upon their experience, judgment, and needs.
    Device Description
    Vesocclude ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in multiple sizes.
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