BEUDAMED
    Product Code: KBM FDA class 1 21 CFR 874.4420

    Dissector, Tonsil

    Ear, Nose, Throat

    A tonsil dissector is a surgical instrument used during tonsillectomy to bluntly or sharply separate the tonsillar capsule from the surrounding pharyngeal tissue, facilitating complete removal of the tonsils. 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 KBM 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
    66
    Registration Numbers
    66
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KBM
    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
    K940903 TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES

    FEI Numbers

    This FDA classification entry is associated with 66 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 66 registration numbers. Click on an entry to view related FDA registrations.