BEUDAMED
    Product Code: FXM FDA class 1 21 CFR 878.4160

    Camera, Still, Endoscopic

    General, Plastic Surgery

    An endoscopic still camera is a photographic device used to capture static images through an endoscope during minimally invasive procedures, providing a visual record of internal anatomy or operative findings. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FXM, 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
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FXM
    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

    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
    K822167 STILL ENDOSCOPIC CAMERAS

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.