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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    iTind System

    K Number: K210138 · Decision Jun 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    157

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    Basic Information

    Device Name
    iTind System
    K Number
    K210138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5510
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medi-Tate , Ltd.
    Date Received
    January 19, 2021
    Decision Date
    June 25, 2021
    Product Code
    QKA
    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
    QKA Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QKA), ordered by most recent decision date.

    Urocross Expander System (Model Numbers ES2018 and ES3025)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    iTind System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Medi-Tate , Ltd.

    K Number Device Name
    DEN190020 iTind System