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

    Niti-S SPAXUS Stent

    K Number: K252648 · Decision Mar 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    10
    Applicant Total
    16
    Review Days
    204

    Basic Information

    Device Name
    Niti-S SPAXUS Stent
    K Number
    K252648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5015
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taewoong Medical Co., Ltd.
    Date Received
    August 21, 2025
    Decision Date
    March 13, 2026
    Product Code
    PCU
    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
    PCU Pancreatic Stent, Covered, Metallic, Removable

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    Other Clearances by Taewoong Medical Co., Ltd.

    K Number Device Name
    K260962 Sphincterotome
    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
    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. →