BEUDAMED
    Product Code: KBG FDA class 1 21 CFR 874.4420

    Trocar, Sinus

    Ear, Nose, Throat

    A sinus trocar is a sharp-pointed, hollow surgical instrument used in ENT procedures to puncture the wall of a paranasal sinus, most commonly the maxillary sinus, to establish access for drainage, irrigation, or tissue sampling. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls and not requiring premarket notification. Product code KBG is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.

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    510(k)s
    3
    FEI Numbers
    24
    Registration Numbers
    24
    Unique Applicants
    3
    Years Active
    20

    Basic Information

    Product Code
    KBG
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K033591 REPROCESSED TROCARS
    K013987 REPROCESSED DISPOSABLE TROCARS
    K844186 CONTINENT STOMA SYSTEM & ACCESSORIES

    FEI Numbers

    This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.