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

    Pathfinder Endoscope Overtube

    K Number: K211301 · Decision May 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    Pathfinder Endoscope Overtube
    K Number
    K211301
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neptune Medical, Inc.
    Date Received
    April 29, 2021
    Decision Date
    May 28, 2021
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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    Other Clearances by Neptune Medical, Inc.

    K Number Device Name
    K240853 Pathfinder® CR System
    K230801 Pathfinder Endoscope Overtube with Balloon Device
    K210915 Pathfinder Endoscope Cap
    K191415 Pathfinder Endoscope Overtube