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510(k) Data Aggregation

    K Number
    K080780
    Device Name
    ANCHORAGE SCOPE, MODEL 000003
    Manufacturer
    EPITEK, INC.
    Date Cleared
    2008-07-30

    (133 days)

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

    EPITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anchorage™ Scope is a flexible fiber optic endoscope intended for the visualization of body cavities, organs, canals, and tissues. The Anchorage Scope is designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The Anchorage Scope is indicated for the following applications: Ureteroscopy Bronchoscopy Thoracoscopy Nasopharyngoscopy/Sinuscopy General laparascopy Urology Gynecology
    Device Description
    The Anchorage™ Scope is a flexible fiber optic endoscope provided as a sterile single use device. The endoscope is used to visualize body cavities, organs, canals, and tissues. The Anchorage Scope is introduced through natural body cavities or surgical incisions through introducers or trocars, catheters, sheaths or other devices of with lumens having an inside diameter greater than the outside diameter of the endoscope.
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    K Number
    K073507
    Device Name
    ANCHORAGE ACCESS KIT
    Manufacturer
    EPITEK, INC.
    Date Cleared
    2008-03-05

    (83 days)

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

    EPITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anchorage™ Access Kit facilitates percutaneous access in order to establish a guide through which surgical instruments or devices can be intubated.
    Device Description
    The Anchorage Access Kit is a system of components used to gain percutaneous access and provide a conduit for the Anchorage Closure Device (K073096) or other surgical instruments.
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    K Number
    K073096
    Device Name
    ANCHORAGE CLOSURE DEVICE
    Manufacturer
    EPITEK, INC.
    Date Cleared
    2008-02-07

    (98 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anchorage™ Closure Device facilitates placement of a pre-tied ligature for use in surgical applications where soft tissue must be approximated and/or ligated.
    Device Description
    The Anchorage Closure Device is a one piece, single-use system comprised of components used to deliver and deploy a pre-tied suture in order to achieve soft tissue approximation and/or ligation.
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