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

    Genistrong

    K Number: K180836 · Decision Apr 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    19

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    Basic Information

    Device Name
    Genistrong
    K Number
    K180836
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genicon, Inc.
    Date Received
    March 30, 2018
    Decision Date
    April 18, 2018
    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 Genicon, Inc.

    K Number Device Name
    K190168 Aquas Probes
    K181791 SIMPLYSTRONG, SIMPLYEZEE
    K180579 Ezee Retrieval
    K171752 X-SURGE
    K162059 EZEE RETRIEVAL