BEUDAMED
    Product Code: KBQ FDA class 1 21 CFR 874.4420

    Knife, Tonsil

    Ear, Nose, Throat

    A tonsil knife is a surgical blade instrument used during tonsillectomy to incise and dissect tonsillar tissue from the surrounding pharyngeal pillar mucosa and underlying muscle. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KBQ 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
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KBQ
    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
    K841005 TONSIL KNIFE-VARIOUS

    FEI Numbers

    This FDA classification entry is associated with 50 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 50 registration numbers. Click on an entry to view related FDA registrations.