BEUDAMED
    Product Code: KAA FDA class 1 21 CFR 874.4420

    Set, Laryngeal Injection

    Ear, Nose, Throat

    A laryngeal injection set is a collection of instruments used in otolaryngology to deliver therapeutic substances, such as Teflon or other augmentation materials, directly into the laryngeal tissues to treat conditions such as vocal cord paralysis. It is an FDA Class 1 device subject only to general controls, reflecting its low-risk classification that does not require premarket clearance. Product code KAA 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
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KAA
    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 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.