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

    Iovera System

    K Number: K211334 · Decision Sep 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    130

    Basic Information

    Device Name
    Iovera System
    K Number
    K211334
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4250
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pacira Pharmaceuticals Inc.
    Date Received
    May 3, 2021
    Decision Date
    September 10, 2021
    Product Code
    GXH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXH Device, Surgical, Cryogenic

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