BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    SIRIUS Endoscope System

    K Number: K221642 · Decision Dec 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    2
    Review Days
    189

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    Basic Information

    Device Name
    SIRIUS Endoscope System
    K Number
    K221642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Robotics (Hong Kong) Limited
    Date Received
    June 6, 2022
    Decision Date
    December 12, 2022
    Product Code
    HET
    Advisory Committee
    Obstetrics/Gynecology
    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
    HET Laparoscope, Gynecologic (And Accessories)

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    Other Clearances by Precision Robotics (Hong Kong) Limited

    K Number Device Name
    K250939 SIRIUS Endoscope System (PR-SI-1230)