BEUDAMED
    Product Code: FWI FDA class 1 21 CFR 878.4160

    Camera, Cine, Surgical, With Audio

    General, Plastic Surgery

    A surgical cine camera with audio is a motion picture and sound recording device used to capture complete audiovisual records of surgical procedures, supporting education, documentation, and review. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FWI, regulated under 21 CFR 878.4160, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    FWI
    Device Class
    FDA class 1
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.