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
    Why did this record match?
    Product Code :

    GYK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1