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

    Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

    K Number: K251123 · Decision Dec 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    16
    Review Days
    262

    Basic Information

    Device Name
    Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
    K Number
    K251123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Taewoong Medical Co., Ltd.
    Date Received
    April 11, 2025
    Decision Date
    December 29, 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 Taewoong Medical Co., Ltd.

    K Number Device Name
    K260962 Sphincterotome
    K252648 Niti-S SPAXUS Stent
    K243619 Niti-S Esophageal Stent; Esophageal TTS Stent
    K250663 Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
    K223067 Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
    K223626 Niti-S Biliary Speed D Stent
    K223256 Optimos™ Cystotome
    K221482 Esophageal TTS Stent
    K221071 Niti-S Biliary Slim M Stent
    K211706 Esophageal TTS Stent
    Search all 16 clearances from Taewoong Medical Co., Ltd. →