BEUDAMED
    Product Code: FAZ FDA class 2 21 CFR 878.4350

    System, Cryosurgical, Liquid Nitrogen, For Urology

    General, Plastic Surgery

    The Liquid Nitrogen Cryosurgical System for Urology (product code FAZ) is a device that uses liquid nitrogen to freeze and destroy unwanted tissue in urological applications, such as in the treatment of prostate conditions or urological tumors. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 878.4350 in the General and Plastic Surgery specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Research product code FAZ in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    FAZ
    Device Class
    FDA class 2
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting