BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Geon (S2) Nasal Aspirator

    K Number: K243138 · Decision Feb 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    151
    Applicant Total
    2
    Review Days
    127

    Basic Information

    Device Name
    Geon (S2) Nasal Aspirator
    K Number
    K243138
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geon Corporation
    Date Received
    September 30, 2024
    Decision Date
    February 4, 2025
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Geon Corporation

    K Number Device Name
    K220126 Geonic Nasal Aspirator, Geonic Nasal Cleaner