BEUDAMED
    Product Code: FWY FDA class 1 21 CFR 878.4950

    Table, Operating-Room, Non-Electrical

    General, Plastic Surgery

    A non-electrical operating room table is a patient support surface used in surgical settings that relies entirely on non-powered mechanical systems for positioning, without electrical actuation. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FWY, regulated under 21 CFR 878.4950, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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    510(k)s
    4
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    4
    Years Active
    9

    Basic Information

    Product Code
    FWY
    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 4 510(k) clearances via K numbers.

    K Number Device Name
    K883457 ASST-3000 SPINAL SURGERY TABLE
    K873478 SKYTRON MODEL 130 SURGICAL TABLE
    K833509 CHEMONUCLEOLYSIS TABLE
    K800118 CHICK SURGICAL TABLE

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.