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

    WalterLorenz Surgical Assist Arm Scope Holder

    K Number: K190576 · Decision Jun 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    25
    Review Days
    91

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    Basic Information

    Device Name
    WalterLorenz Surgical Assist Arm Scope Holder
    K Number
    K190576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Microfixation
    Date Received
    March 6, 2019
    Decision Date
    June 5, 2019
    Product Code
    OCV
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCV Endoscope Holder

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