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

    Rezum System

    K Number: K160417 · Decision Mar 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    3
    Review Days
    30

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    Basic Information

    Device Name
    Rezum System
    K Number
    K160417
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nxthera, Inc.
    Date Received
    February 16, 2016
    Decision Date
    March 17, 2016
    Product Code
    KNS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Nxthera, Inc.

    K Number Device Name
    K180237 Rezum System
    K150786 Rezum System