BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ARTHROCARE DENTAL ELECTROSURGERY SYSTEM

    K Number: K962445 · Decision Jul 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    18
    Applicant Total
    112
    Review Days
    36

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    Basic Information

    Device Name
    ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
    K Number
    K962445
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arthrocare Corp.
    Date Received
    June 24, 1996
    Decision Date
    July 30, 1996
    Product Code
    EKZ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EKZ Unit, Electrosurgical, And Accessories, Dental

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