BEUDAMED
    Product Code: KBA FDA class 1 21 CFR 874.4420

    Rasp, Nasal

    Ear, Nose, Throat

    A nasal rasp is a surgical hand instrument used in rhinoplasty and septoplasty to smooth or contour nasal bone and cartilage by abrading irregular surfaces, typically after osteotomy or fracture reduction. It is classified as an FDA Class 1 device, subject only to general controls and not requiring premarket clearance. Product code KBA 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
    83
    Registration Numbers
    83
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    KBA
    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 83 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 83 registration numbers. Click on an entry to view related FDA registrations.