BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    STRYKER ESSX MICRODEBRIDER SYSTEM

    K Number: K073633 · Decision Aug 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    2
    Review Days
    244

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    Basic Information

    Device Name
    STRYKER ESSX MICRODEBRIDER SYSTEM
    K Number
    K073633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Ireland Ltd., Instruments Division
    Date Received
    December 26, 2007
    Decision Date
    August 26, 2008
    Product Code
    ERL
    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
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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    Other Clearances by Stryker Ireland Ltd., Instruments Division

    K Number Device Name
    K082010 STRYKER DISPOSABLE CRANIAL PERFORATOR BIT