BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000

    K Number: K980588 · Decision Aug 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    22
    Review Days
    182

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    Basic Information

    Device Name
    CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
    K Number
    K980588
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarus Medical Systems, Inc.
    Date Received
    February 17, 1998
    Decision Date
    August 18, 1998
    Product Code
    GAD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAD Retractor

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