BEUDAMED
    Product Code: FZM FDA class 1 21 CFR 878.4950

    Stool, Operating-Room

    General, Plastic Surgery

    The Stool, Operating-Room (product code FZM) is a stool designed for use by surgical personnel in the operating room, providing seated support during procedures. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4950 within the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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    510(k)s
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    FZM
    Device Class
    FDA class 1
    Regulation Number
    878.4950
    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
    K890309 MALIS SURGICAL STOOL

    FEI Numbers

    This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.