BEUDAMED
    Product Code: JYP FDA class 1 21 CFR 874.4420

    Knife, Myringotomy

    Ear, Nose, Throat

    Knife, Myringotomy is a surgical blade instrument used to make a controlled incision in the tympanic membrane (eardrum) during a myringotomy procedure, allowing drainage of middle ear fluid and placement of a ventilation tube. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JYP, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.

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    510(k)s
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    JYP
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K822162 MYRINGOTOMY KNIFE (VARIOUS TYPES)

    FEI Numbers

    This FDA classification entry is associated with 42 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 42 registration numbers. Click on an entry to view related FDA registrations.