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

    Video Endoscopy System, 3D Video Endoscopy System

    K Number: K210116 · Decision Oct 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    7
    Review Days
    267

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    Basic Information

    Device Name
    Video Endoscopy System, 3D Video Endoscopy System
    K Number
    K210116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
    Date Received
    January 19, 2021
    Decision Date
    October 13, 2021
    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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