BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    IceSense 3, ProSense, MultiSense

    K Number: K183213 · Decision Dec 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    4
    Review Days
    396

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    Basic Information

    Device Name
    IceSense 3, ProSense, MultiSense
    K Number
    K183213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    IceCure Medical , Ltd.
    Date Received
    November 19, 2018
    Decision Date
    December 20, 2019
    Product Code
    GEH
    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
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by IceCure Medical , Ltd.

    K Number Device Name
    K260377 XSense Cryoablation System with CryoProbes
    K240892 XSense Cryoablation System with Cryoprobes
    K102360 ICESENCE 3