BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Sutter CURIS RF Generator

    K Number: K171869 · Decision Feb 23, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    9
    Review Days
    246

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    Basic Information

    Device Name
    Sutter CURIS RF Generator
    K Number
    K171869
    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
    Sutter Medizintechnik GmbH
    Date Received
    June 22, 2017
    Decision Date
    February 23, 2018
    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 Sutter Medizintechnik GmbH

    K Number Device Name
    K251813 CURIS II RF Generator (REF 360100-05)
    K233425 FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
    K193587 Sutter Swyng non-stick bipolar forceps, single-use
    K192128 Sutter Arrowtip Monopolar Electrodes
    K191732 Sutter RaVoR Bipolar Electrodes
    K150959 Sutter Bipolar Forceps-Calvian
    K131012 SUTTER BIPOLAR FORCEPS - SUPERGLISS
    K073450 SUTTER ELECTROSURGICAL CABLES