BEUDAMED
    Product Code: KBN FDA class 1 21 CFR 874.4420

    Gag, Mouth

    Ear, Nose, Throat

    A mouth gag is a device used in otolaryngological and oral surgical procedures to hold the patient's mouth open and maintain access to the oropharynx, allowing the surgeon to operate on the tonsils, adenoids, or other throat structures. 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 KBN 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
    3
    FEI Numbers
    204
    Registration Numbers
    204
    Unique Applicants
    3
    Years Active
    6

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    Basic Information

    Product Code
    KBN
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K834540 OP-CON SURGICAL INSTRUMENT #9
    K822183 MOUTH GAGS
    K780992 MILLARD MOUTH GAG

    FEI Numbers

    This FDA classification entry is associated with 204 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 204 registration numbers. Click on an entry to view related FDA registrations.