BEUDAMED
    Product Code: KBJ FDA class 1 21 CFR 874.4420

    Curette, Adenoid

    Ear, Nose, Throat

    An adenoid curette is a spoon-shaped surgical scraping instrument used to remove adenoid tissue from the posterior nasopharynx during adenoidectomy procedures, typically in children suffering from recurrent otitis media or obstructive breathing. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. Product code KBJ 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
    77
    Registration Numbers
    77
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KBJ
    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
    K822189 BECKMAN ADENOID CURRETTE

    FEI Numbers

    This FDA classification entry is associated with 77 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 77 registration numbers. Click on an entry to view related FDA registrations.