BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    CELON ENT SYSTEM

    K Number: K032838 · Decision Sep 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    2
    Review Days
    15

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    Basic Information

    Device Name
    CELON ENT SYSTEM
    K Number
    K032838
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Celon AG Medical Instruments
    Date Received
    September 11, 2003
    Decision Date
    September 26, 2003
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Celon AG Medical Instruments

    K Number Device Name
    K073207 OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167