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510(k) Data Aggregation

    K Number
    K990782
    Device Name
    DAUM NEUROGATE TROCAR
    Manufacturer
    DAUM GMBH
    Date Cleared
    1999-04-28

    (50 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.

    Device Description

    The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Daum NeuroGate Trocar". This document only states that the device is substantially equivalent to a predicate device and can be marketed. It does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the given context. The document is a regulatory approval, not a scientific study report.

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