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

    DYNE PORT

    K Number: K252933 · Decision Jun 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    71
    Applicant Total
    2
    Review Days
    270

    Basic Information

    Device Name
    DYNE PORT
    K Number
    K252933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dyne Medical Group, Inc.
    Date Received
    September 15, 2025
    Decision Date
    June 12, 2026
    Product Code
    ODC
    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
    ODC Endoscope Channel Accessory

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