BEUDAMED
    Product Code: FGY FDA class 1 21 CFR 878.4200

    Cannula, Injection

    General, Plastic Surgery

    The Injection Cannula is a hollow needle-like instrument used to introduce fluids, medications, or other substances into tissues during general or plastic surgery procedures. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls with no premarket notification required. The product code is FGY, regulated under 21 CFR 878.4200, within the General, Plastic Surgery medical specialty.

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    510(k)s
    2
    FEI Numbers
    82
    Registration Numbers
    82
    Unique Applicants
    2
    Years Active
    6

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    Basic Information

    Product Code
    FGY
    Device Class
    FDA class 1
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K822201 EAR CANNULAS
    K760389 CANNULA, IV

    FEI Numbers

    This FDA classification entry is associated with 82 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 82 registration numbers. Click on an entry to view related FDA registrations.