BEUDAMED
    Product Code: JYI FDA class 1 21 CFR 874.4420

    Gauge, Mastoid

    Ear, Nose, Throat

    Gauge, Mastoid is a surgical measuring instrument used to assess dimensions within the mastoid cavity during mastoid surgery, assisting the surgeon in determining the extent of bone removal or the size of structures encountered during the procedure. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JYI, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.

    View on FDA
    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    JYI
    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 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.