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510(k) Data Aggregation

    K Number
    K081366
    Device Name
    KUMAR T-ANCHORS HERNIA SET
    Manufacturer
    NASHVILLE SURGICAL INSTRUMENTS
    Date Cleared
    2008-07-15

    (61 days)

    Product Code
    GAR,GDW
    Regulation Number
    878.5020
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K963999,K032478
    Why did this record match?
    Device Name :

    KUMAR T-ANCHORS HERNIA SET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Kumar T-ANCHORS Hernia Set provides a means for fixation of prosthetic material and passage of sufure during repair of hernia and soft tissue.

    Device Description

    Kumar T-Anchors Hernia Set supplies 8 T-Anchors that carry size 0 polyamide suture. These are deployed in pairs percutaneously through a 16 ga, needle. The sutures are tied to anchor the prosthetic material to the abdominal wall in repair of hernia or the soft tissues.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria, as it does not include details on a performance study or testing with specific metrics.

    The document is a 510(k) premarket notification letter from the FDA regarding the "Kumar T-ANCHORS Hernia Set". It primarily discusses the device's substantial equivalence to predicate devices and regulatory compliance.

    Therefore, I cannot generate the requested table and information points.

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