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

    Agile Esophageal OTW Stent System

    K Number: K211960 · Decision Nov 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    58
    Applicant Total
    231
    Review Days
    151

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    Basic Information

    Device Name
    Agile Esophageal OTW Stent System
    K Number
    K211960
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corporation
    Date Received
    June 24, 2021
    Decision Date
    November 22, 2021
    Product Code
    ESW
    Advisory Committee
    General, Plastic Surgery
    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
    ESW Prosthesis, Esophageal

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    Esophageal TTS Stent

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