BEUDAMED
    Product Code: CAL FDA class 1 21 CFR 868.5530

    Laryngoscope, Non-Rigid

    Anesthesiology

    The Non-Rigid Laryngoscope is an anesthesiology device used to visualize the larynx and vocal cords during intubation, featuring a flexible or articulating design that allows navigation of the airway in patients with difficult or unusual anatomy. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CAL, regulated under 21 CFR 868.5530, within the Anesthesiology medical specialty. No special flags apply to this device.

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    510(k)s
    8
    FEI Numbers
    56
    Registration Numbers
    56
    Unique Applicants
    5
    Years Active
    16

    Basic Information

    Product Code
    CAL
    Device Class
    FDA class 1
    Regulation Number
    868.5530
    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

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    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K951195 FI-10P
    K951194 FI-10M
    K872895 HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.
    K852994 REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11
    K850978 OLYMPUS LF-1 INTUBATION SCOPE
    K802331 AO FLEXIBLE LARYNGOSCOPE, #LS-7
    K801364 AO STYLET LARYNGOSCOPE MODEL SLS
    K791634 AO STYLET LARYNGOSCOPE, MODEL SLS-1

    FEI Numbers

    This FDA classification entry is associated with 56 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.