BEUDAMED
    Product Code: FZY FDA class 1 21 CFR 878.4800

    Hammer, Surgical

    General, Plastic Surgery

    The Hammer, Surgical (product code FZY) is a manual surgical mallet used in general and plastic surgery to deliver controlled force to chisels, osteotomes, or other instruments during bone work or tissue manipulation procedures. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    271
    Registration Numbers
    271
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FZY
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K802524 SURGICAL HAMMERS

    FEI Numbers

    This FDA classification entry is associated with 271 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 271 registration numbers. Click on an entry to view related FDA registrations.