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

    ActivSight Intraoperative Imaging System

    K Number: K203550 · Decision Apr 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    125

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    Basic Information

    Device Name
    ActivSight Intraoperative Imaging System
    K Number
    K203550
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Activ Surgical, Inc.
    Date Received
    December 4, 2020
    Decision Date
    April 8, 2021
    Product Code
    OWN
    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
    OWN Confocal Optical Imaging

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    Other Clearances by Activ Surgical, Inc.

    K Number Device Name
    K231344 ActivSight Intraoperative Imaging System