BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇳🇿 New Zealand

    Chitogel Endoscopic Sinus Surgery Kit

    K Number: K172179 · Decision Oct 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    45
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    Chitogel Endoscopic Sinus Surgery Kit
    K Number
    K172179
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4780
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chitogel, Ltd.
    Date Received
    July 19, 2017
    Decision Date
    October 17, 2017
    Product Code
    LYA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYA Splint, Intranasal Septal

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