BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Uni-port

    K Number: K232062 · Decision Jan 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    189

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    Basic Information

    Device Name
    Uni-port
    K Number
    K232062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dalim Medical Corp.
    Date Received
    July 11, 2023
    Decision Date
    January 16, 2024
    Product Code
    OTJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OTJ Laparoscopic Single Port Access Device

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