BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NAVARRE PERCUTANEOUS BILIARY DRAINAGE

    K Number: K955110 · Decision Nov 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    9
    Review Days
    365

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    Basic Information

    Device Name
    NAVARRE PERCUTANEOUS BILIARY DRAINAGE
    K Number
    K955110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Navarre Biomedical , Ltd.
    Date Received
    November 8, 1995
    Decision Date
    November 7, 1996
    Product Code
    FGE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by Navarre Biomedical , Ltd.

    K Number Device Name
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    K951907 NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER
    K951475 NAVARRE UNIVERSAL DRAINAGE CATHETER
    K943663 NAVARRE 600 ML DRAINAGE BAG
    K942315 NAVARRE PERCUTANEOUS ACCESS SET
    K933600 NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS
    K932391 NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET