BEUDAMED
    Product Code: QJL FDA class 1 21 CFR 874.4780

    Splint, Intranasal Septal, Cber Led

    Ear, Nose, Throat

    The Splint, Intranasal Septal (CBER Led) is a Class 1 ear, nose, and throat device used as an intranasal septal splint following nasal or septal surgery to support and stabilize the nasal septum during healing. It is exempt from 510(k) premarket notification and is regulated under 21 CFR 874.4780 within the Ear, Nose, and Throat medical specialty. The product code is QJL. The device is not an implant and is not life-sustaining.

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

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    Basic Information

    Product Code
    QJL
    Device Class
    FDA class 1
    Regulation Number
    874.4780
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    4

    Device Characteristics

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

    Definition

    Splint, Intranasal Septal, CBER led

    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
    K160101 SinuBand

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.