BEUDAMED
    Product Code: KBF FDA class 1 21 CFR 874.4420

    Trephine, Sinus

    Ear, Nose, Throat

    A sinus trephine is a surgical instrument used to create a circular opening in the bony wall of a paranasal sinus, typically the frontal sinus, to allow drainage, irrigation, or access for therapeutic intervention. It is classified as an FDA Class 1 device, subject only to general controls and not requiring premarket clearance. Product code KBF is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KBF
    Device Class
    FDA class 1
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    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
    K802915 MONTG. TRACHEAL TREPHINE FENE STRATOR

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.