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

    VERSAJET Hydrosurgery System (III)

    K Number: K220964 · Decision May 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    52
    Applicant Total
    19
    Review Days
    410

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    Basic Information

    Device Name
    VERSAJET Hydrosurgery System (III)
    K Number
    K220964
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5475
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Medical Limited
    Date Received
    April 1, 2022
    Decision Date
    May 16, 2023
    Product Code
    FQH
    Advisory Committee
    General Hospital
    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
    FQH Lavage, Jet

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