BEUDAMED
    Product Code: FZO FDA class 1 21 CFR 878.4800

    Chisel, Surgical, Manual

    General, Plastic Surgery

    The Chisel, Surgical, Manual (product code FZO) is a manually operated surgical instrument used to cut or shape bone and hard tissue during general or plastic surgery procedures. It is classified as FDA Class 1, subject only to general controls, with no premarket notification required, as it poses the lowest level of risk. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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    510(k)s
    2
    FEI Numbers
    249
    Registration Numbers
    249
    Unique Applicants
    2
    Years Active
    1

    Basic Information

    Product Code
    FZO
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K851788 29-140 TO 29-196 VARIOUS BONE CHISELS (OSTEOTOMES,
    K834198 JAKOBI SURG. INSTRUMENTS #12 40/41

    FEI Numbers

    This FDA classification entry is associated with 249 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 249 registration numbers. Click on an entry to view related FDA registrations.