BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    ProSense™ System

    K Number: DEN220077 · Decision Oct 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    1080

    Basic Information

    Device Name
    ProSense™ System
    K Number
    DEN220077
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4355
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Icecure Medical
    Date Received
    October 19, 2022
    Decision Date
    October 3, 2025
    Product Code
    QXW
    Advisory Committee
    General, Plastic Surgery
    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
    QXW Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer