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510(k) Data Aggregation

    K Number
    K080836
    Device Name
    MODIFICATION TO ENDOFAST RELIANT SYSTEM
    Manufacturer
    ENDOGUN MEDICAL SYSTEMS
    Date Cleared
    2008-04-21

    (27 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOGUN MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoFast Reliant™ System is indicated for fixation of surgical mesh to tissues for tissue reinforcement during minimally invasive procedures.
    Device Description
    The EndoFast Reliant™ System is a sterile, single use system, consisting of the following componnents: 1. Plastic Fixation Devices (X5) and a Handle. Each Fixation Device is preloaded with a Spider Fastener. The Spider Fastener is provided with a Retrieval Unit, which together with the Extraction Device (described below), enables facile retrieval of the deployed Fastener when needed. 2. A plastic Extraction Device, provided for easy removal of the Fastener when needed, under direct vision. 3. Polypropylene monofilament Surgical Mesh
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    K Number
    K060329
    Device Name
    ENDOFAST RELIANT SYSTEM
    Manufacturer
    ENDOGUN MEDICAL SYSTEMS
    Date Cleared
    2006-09-11

    (214 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOGUN MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoFast Reliant System is indicated for fixation of surgical mesh to tissues for tissue reinforcement during minimally invasive procedures
    Device Description
    The EndoFast Reliant System is a sterile, single use system consisting of the following components: stainless steel Fixation . A Device preloaded with the Spider Fastener. The Fixation Device is provided with a safety pin that prevents inadvertent deployment of the Spider Fastener. . Surgical Mesh; Polypropylene monofilament Mesh · A stainless steel Extraction Device; provided for easy removal of the Spider Fastener when needed under direct vision. Endogun's EndoFast Reliant System is used to attach or reinforce tissues by fastening them with Spider Fasteners. These Fasteners will attach a suitably designed mesh onto the tissue to ensure fixation between two tissues. The devices are preloaded for single use. The EndoFast Reliant System is supplied sterilized and ready for use upon removal from its packaging. The Fixation Device is provided with a safety pin that prevents inadvertent deployment of the Spider Fastener.
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