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

    RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR

    K Number: K032149 · Decision Sep 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    9
    Review Days
    57

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    Basic Information

    Device Name
    RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
    K Number
    K032149
    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
    Rita Medical Systems, Inc.
    Date Received
    July 14, 2003
    Decision Date
    September 9, 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 Rita Medical Systems, Inc.

    K Number Device Name
    K070101 UNIBLATE ELECTROSURGICAL DEVICE
    K062414 VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
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    K051102 OMNIPICC PI
    K050176 VORTEX EZ VASCULAR ACCESS PORT
    K031926 RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)
    K031257 RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
    K030936 RITA CLIPS FOR INFUSION PUMPS