BEUDAMED
    Product Code: FWJ FDA class 1 21 CFR 878.4160

    Camera, Cine, Microsurgical, Without Audio

    General, Plastic Surgery

    A microsurgical cine camera without audio is a high-magnification motion picture recording device used during microsurgical procedures to document the operative field visually, without an audio track. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FWJ, regulated under 21 CFR 878.4160, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    FWJ
    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 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.