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

    EGIS Biliary Double Bare Stent (BDB080405)

    K Number: K242845 · Decision Jun 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    2
    Review Days
    278

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    Basic Information

    Device Name
    EGIS Biliary Double Bare Stent (BDB080405)
    K Number
    K242845
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    S&G Biotech, Inc.
    Date Received
    September 20, 2024
    Decision Date
    June 25, 2025
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by S&G Biotech, Inc.

    K Number Device Name
    K223354 EGIS Biliary Single Bare Stent