BEUDAMED
    Product Code: KTE FDA class 1 21 CFR 874.4420

    Trocar, Ent

    Ear, Nose, Throat

    This device is an ENT trocar, a sharp or blunt-tipped instrument used in ear, nose, and throat surgery to create an access port or puncture through tissue, such as the nasal sinuses, to facilitate drainage or the passage of surgical instruments. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is KTE, regulated under 21 CFR 874.4420 within the Ear, Nose, and Throat specialty. No special flags apply.

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    510(k)s
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KTE
    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
    K822168 ANTRUM TROCARS

    FEI Numbers

    This FDA classification entry is associated with 84 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 84 registration numbers. Click on an entry to view related FDA registrations.