LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K962761
    Device Name
    REIGEL TUNNELING DEVICE
    Manufacturer
    COOK, INC.
    Date Cleared
    1996-10-11

    (87 days)

    Product Code
    GYK
    Regulation Number
    882.4545
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Reigel Tunneling Device is used for tunneling and passing shunt components under the skin for the placement of cerebrospinal fluid shunts from the head to the abdomen.

    Device Description

    The Reigel Tunneling Device is used for tunneling and passing shunt components under the skin for the placement of cerebrospinal fluid shunts from the head to the abdomen. The device is supplied sterile. The materials comprising the device have an established history of use in medical product manufacturing.

    AI/ML Overview

    This 510(k) Premarket Notification for the Reigel Tunneling Device does not contain any information about acceptance criteria or a study proving the device meets them.

    The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on intended use, materials, and technological characteristics. It is not a clinical study report or a performance evaluation.

    Therefore, I cannot provide the requested information, as it is not present in the input text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1