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

    SurgicalPreview

    K Number: K171534 · Decision Nov 8, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    167

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SurgicalPreview
    K Number
    K171534
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endo Vantage, LLC
    Date Received
    May 25, 2017
    Decision Date
    November 8, 2017
    Product Code
    PZO
    Advisory Committee
    Radiology
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PZO), ordered by most recent decision date.

    Sim&Size

    FDA 510(k)
    FDA Class 2 ·Radiology

    ANKYRAS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sim&Size

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ankyras

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sim&Size

    FDA 510(k)
    FDA Class 2 ·Radiology

    AneuGuide

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all