BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    HyperSnap Surgical System (HSS)

    K Number: K250268 · Decision Jun 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    145

    Basic Information

    Device Name
    HyperSnap Surgical System (HSS)
    K Number
    K250268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hypervision Surgical
    Date Received
    January 30, 2025
    Decision Date
    June 24, 2025
    Product Code
    SFE
    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
    SFE Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation