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

    BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS

    K Number: K945995 · Decision Jan 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    9
    Review Days
    117

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    Basic Information

    Device Name
    BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS
    K Number
    K945995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ximed/Prosure/Injectx
    Date Received
    October 6, 1994
    Decision Date
    January 31, 1995
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Ximed/Prosure/Injectx

    K Number Device Name
    K002269 ELECTROSURGICAL PROBES AND DEVICES-GELTX
    K994151 PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
    K983765 INJECTION NEEDLE PROBE/DEVICE-TUNIS
    K983200 INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
    K981256 ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
    K974484 ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
    K974637 ELECTRODES/PROBES/DEVICES
    K962593 ELECTROSURGICAL PROBES & DEVICES