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

    Bissinger Monopolar Cables

    K Number: K150024 · Decision Feb 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    6
    Review Days
    44

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    Basic Information

    Device Name
    Bissinger Monopolar Cables
    K Number
    K150024
    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
    Guenter Bissinger Medizintechnik GmbH
    Date Received
    January 7, 2015
    Decision Date
    February 20, 2015
    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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    K Number Device Name
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    K051429 CLARIS NON-STICK BIPOLAR FORCEPS
    K042077 BITECH BIPOLAR SCISSORS
    K981919 BISSINGER CABLES, CAT. NO. 801000XX
    K970968 BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS