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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K022410,K060721
    Why did this record match?
    Device Name :

    ANCHORAGE CLOSURE DEVICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that the device meets them. The document is a 510(k) summary for the Epitek Anchorage™ Closure Device, focusing on its substantial equivalence to predicate devices, its description, and its indications for use. It primarily constitutes regulatory correspondence from the FDA.

    Therefore, I cannot fulfill your request for the tables and details about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

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