BEUDAMED
    Product Code: FTS FDA class 1 21 CFR 878.4160

    Camera, Cine, Endoscopic, With Audio

    General, Plastic Surgery

    An endoscopic cine camera with audio is a surgical recording device used to capture motion video and synchronized sound during endoscopic procedures, supporting documentation and education. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FTS, 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
    2
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    1
    Years Active
    0

    Basic Information

    Product Code
    FTS
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K883944 MEC-1 VIDEO COMBO SYSTEM
    K883943 CCM-1 VIDEO CAMERA SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.