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

    Dannik Laparoscopic Suction Irrigation System

    K Number: K192643 · Decision Nov 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    56

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    Basic Information

    Device Name
    Dannik Laparoscopic Suction Irrigation System
    K Number
    K192643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dannik
    Date Received
    September 24, 2019
    Decision Date
    November 19, 2019
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Dannik

    K Number Device Name
    K201063 DANNIK Disposable Monopolar Laparoscopic Instrument
    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