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510(k) Data Aggregation

    K Number
    K992980
    Device Name
    ENGAGE JAW INSERTS
    Manufacturer
    NOVARE SURGICAL SYSTEMS, INC.
    Date Cleared
    2000-06-08

    (279 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENGAGE JAW INSERTS

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

    For Vascular Work
    Suitable for veins and arteries
    ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters.
    ENGAGE Jaw Inserts are adaptable to Fogarty Hydragrip® Surgical Clamps.

    Device Description

    ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters. ENGAGE Jaw Inserts are adaptable to Fogarty Hydra-Grip Surgical Clamps. This surgical clamp is intended for use in vascular surgery.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily a 510(k) summary and FDA clearance letter for the Novare Surgical ENGAGE Inserts, establishing its substantial equivalence to predicate devices. It focuses on the device's intended use, classification, and regulatory approval.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study given the input.

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