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

    DANNIK Disposable Monopolar Laparoscopic Instrument

    K Number: K201063 · Decision Jun 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    5
    Review Days
    49

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    Basic Information

    Device Name
    DANNIK Disposable Monopolar Laparoscopic Instrument
    K Number
    K201063
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dannik
    Date Received
    April 21, 2020
    Decision Date
    June 9, 2020
    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 Dannik

    K Number Device Name
    K200053 DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
    K193019 DANNIK Disposable Monopolar Laparoscopic Instrument
    K192711 Dannik Titanium Ligation Clip
    K192643 Dannik Laparoscopic Suction Irrigation System