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

    DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)

    K Number: K200053 · Decision Apr 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    102

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    Basic Information

    Device Name
    DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
    K Number
    K200053
    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
    January 10, 2020
    Decision Date
    April 21, 2020
    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
    K193019 DANNIK Disposable Monopolar Laparoscopic Instrument
    K192711 Dannik Titanium Ligation Clip
    K192643 Dannik Laparoscopic Suction Irrigation System