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

    AXIOS Stent with Electrocautery Enhanced Delivery System

    K Number: K150692 · Decision Aug 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    9
    Applicant Total
    430
    Review Days
    140

    Basic Information

    Device Name
    AXIOS Stent with Electrocautery Enhanced Delivery System
    K Number
    K150692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5015
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BOSTON SCIENTIFIC CORP.
    Date Received
    March 18, 2015
    Decision Date
    August 5, 2015
    Product Code
    PCU
    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
    PCU Pancreatic Stent, Covered, Metallic, Removable

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