BEUDAMED
    Product Code: LNZ FDA class 2 21 CFR 868.5730

    Changer, Tube, Endotracheal

    Anesthesiology

    Changer, Tube, Endotracheal is a device used to facilitate the exchange of an endotracheal tube while maintaining airway access during the procedure, typically a long flexible catheter that remains in the trachea to guide placement of a new endotracheal tube or to provide supplemental oxygen during the exchange. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LNZ, regulated under 21 CFR 868.5730, within the Anesthesiology medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LNZ
    Device Class
    FDA class 2
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    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
    K102127 ENDOTRACHEAL TUBE CHANGERS

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.