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

    HD Mediastinoscope

    K Number: K213194 · Decision Jun 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    10
    Applicant Total
    25
    Review Days
    267

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    Basic Information

    Device Name
    HD Mediastinoscope
    K Number
    K213194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4720
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz Endoscopy America, Inc.
    Date Received
    September 29, 2021
    Decision Date
    June 23, 2022
    Product Code
    EWY
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EWY Mediastinoscope, Surgical

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