BEUDAMED
    Product Code: KCE FDA class 1 21 CFR 878.4800

    Cannulae, Bronchial

    General, Plastic Surgery

    Bronchial cannulae are hollow tubular instruments inserted into the bronchi to facilitate ventilation, suction, or the introduction of fluids or gases during surgical or bronchoscopic procedures of the lower respiratory tract. They are classified as FDA Class 1 devices, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KCE is regulated under 21 CFR 878.4800 in the General, Plastic Surgery medical specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KCE
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    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 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.