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

    Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent

    K Number: K223067 · Decision Jun 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    5
    Applicant Total
    16
    Review Days
    264

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    Basic Information

    Device Name
    Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
    K Number
    K223067
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taewoong Medical Co., Ltd.
    Date Received
    September 23, 2022
    Decision Date
    June 14, 2023
    Product Code
    MUM
    Advisory Committee
    General, Plastic Surgery
    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
    MUM Stent, Metallic, Expandable, Duodenal

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    Other Clearances by Taewoong Medical Co., Ltd.

    K Number Device Name
    K260962 Sphincterotome
    K252648 Niti-S SPAXUS Stent
    K251123 Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
    K243619 Niti-S Esophageal Stent; Esophageal TTS Stent
    K250663 Niti-S Duodenal Comfort 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. →