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

    HANAROSTENT Trachea/Bronchium (CCC)

    K Number: K201342 · Decision Dec 31, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    44
    Applicant Total
    14
    Review Days
    225

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    Basic Information

    Device Name
    HANAROSTENT Trachea/Bronchium (CCC)
    K Number
    K201342
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3720
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    M.I.Tech Co., Ltd.
    Date Received
    May 20, 2020
    Decision Date
    December 31, 2020
    Product Code
    JCT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JCT Prosthesis, Tracheal, Expandable

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    K183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
    K180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
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