BEUDAMED
    Product Code: KBZ FDA class 1 21 CFR 874.4420

    Snare, Tonsil

    Ear, Nose, Throat

    A tonsil snare is a surgical instrument comprising a wire loop that is placed around the tonsil and tightened to sever the tonsillar pedicle during tonsillectomy, providing a controlled method of tissue excision. 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 KBZ 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
    70
    Registration Numbers
    70
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KBZ
    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
    K822188 TONSIL SNARES

    FEI Numbers

    This FDA classification entry is associated with 70 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 70 registration numbers. Click on an entry to view related FDA registrations.