BEUDAMED
    Product Code: KCA FDA class 1 21 CFR 874.4420

    Tonsillectome

    Ear, Nose, Throat

    A tonsillectome is a specialized surgical instrument designed specifically to excise the tonsils, typically combining a cutting element with a means of tissue capture, used during tonsillectomy procedures in patients with recurrent tonsillitis or airway obstruction. 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 KCA 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
    21
    Registration Numbers
    21
    Unique Applicants
    1
    Years Active
    —

    Research product code KCA in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    KCA
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K822186 MACKENZIE'S TONSILLECTOME

    FEI Numbers

    This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.