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

    Endoscopic Applicator, 41 cm

    K Number: K172672 · Decision Oct 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    31

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    Basic Information

    Device Name
    Endoscopic Applicator, 41 cm
    K Number
    K172672
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micromedics, Inc. (D/B/A Nordson Medical)
    Date Received
    September 5, 2017
    Decision Date
    October 6, 2017
    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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    K Number Device Name
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