BEUDAMED
    Product Code: CBG FDA class 1 21 CFR 868.5760

    Spreader, Cuff

    Anesthesiology

    The Cuff Spreader is a simple anesthesiology accessory used to assist with the fitting or adjustment of cuffs on tracheal or other airway tubes, ensuring proper placement and inflation of the cuff to maintain airway sealing. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is CBG, regulated under 21 CFR 868.5760, within the Anesthesiology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.

    View on FDA
    510(k)s
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    1
    Years Active
    —

    Research product code CBG in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    CBG
    Device Class
    FDA class 1
    Regulation Number
    868.5760
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K870600 SOFT EAR STETHOSCOPE

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.