BEUDAMED
    Product Code: PHS FDA class 1 21 CFR 868.5110

    Oral Airway Assist

    Anesthesiology

    The Oral Airway Assist is an anesthesiology device designed to assist in maintaining an open airway in patients, typically used during procedural sedation or to support airway patency. It is an FDA Class 1 device regulated under 21 CFR 868.5110, subject to general controls and eligible for 510(k) exemption under the De Novo pathway. The product code is PHS, within the Anesthesiology (AN) medical specialty. This device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PHS
    Device Class
    FDA class 1
    Regulation Number
    868.5110
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    4

    Device Characteristics

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

    Definition

    To assist in maintaining an open airway.

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.