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

    Pathfinder Endoscope Cap

    K Number: K210915 · Decision May 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    74
    Applicant Total
    5
    Review Days
    57

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    Basic Information

    Device Name
    Pathfinder Endoscope Cap
    K Number
    K210915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neptune Medical, Inc.
    Date Received
    March 29, 2021
    Decision Date
    May 25, 2021
    Product Code
    FDS
    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
    FDS Gastroscope And Accessories, Flexible/Rigid

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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
    K211301 Pathfinder Endoscope Overtube
    K191415 Pathfinder Endoscope Overtube