BEUDAMED
    Product Code: OGS FDA class 2 21 CFR 874.3880

    Myringotomy Procedure Kit

    Ear, Nose, Throat

    The Myringotomy Procedure Kit is a convenience kit used for the myringotomy procedure, in which a small incision is made in the eardrum to drain fluid from the middle ear, often combined with tympanostomy tube placement. Classified as FDA Class 2 under regulation 21 CFR 874.3880 within the Ear, Nose, Throat medical specialty, it is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all criteria are satisfied. The product code is OGS. It is not flagged as an implant or life-sustaining device.

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    510(k)s
    0
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    OGS
    Device Class
    FDA class 2
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.