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

    ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

    K Number: K221872 · Decision Mar 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    275

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    Basic Information

    Device Name
    ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
    K Number
    K221872
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nova Eye Inc. (Business Name Nova Eye Medical)
    Date Received
    June 28, 2022
    Decision Date
    March 30, 2023
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MPA Endoilluminator

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