BEUDAMED
    Product Code: KBB FDA class 1 21 CFR 874.4420

    Rongeur, Nasal

    Ear, Nose, Throat

    A nasal rongeur is a strong, pincer-like surgical cutting instrument used in ENT and plastic surgery to bite away and remove small pieces of nasal bone or cartilage during rhinoplasty, septoplasty, or turbinate procedures. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls without premarket clearance requirements. Product code KBB 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
    81
    Registration Numbers
    81
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KBB
    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 81 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 81 registration numbers. Click on an entry to view related FDA registrations.