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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)

    K Number: K190744 · Decision Aug 29, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    43
    Review Days
    160

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    Basic Information

    Device Name
    ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
    K Number
    K190744
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Winter & Ibe GmbH
    Date Received
    March 22, 2019
    Decision Date
    August 29, 2019
    Product Code
    HET
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HET Laparoscope, Gynecologic (And Accessories)

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