BEUDAMED
    Product Code: KBT FDA class 1 21 CFR 874.4420

    Punch, Tonsil

    Ear, Nose, Throat

    A tonsil punch is a surgical cutting instrument used to remove or trim tonsillar tissue during tonsillectomy or tonsil reduction procedures, using a biting mechanism to excise targeted tissue. 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 KBT 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
    0
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KBT
    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

    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.