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

    truFreeze System

    K Number: K163244 · Decision May 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    14
    Review Days
    187

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    Basic Information

    Device Name
    truFreeze System
    K Number
    K163244
    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
    CSA Medical, Inc.
    Date Received
    November 18, 2016
    Decision Date
    May 24, 2017
    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 CSA Medical, Inc.

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    K161557 truFreeze System
    K152668 truFreeze System
    K150920 truFreeze System
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