BEUDAMED
    Product Code: HGD FDA class 1 21 CFR 884.4520

    Applicator, Vaginal

    Obstetrics/Gynecology

    The Vaginal Applicator is a device used to insert medications, creams, or other therapeutic agents into the vaginal canal, ensuring proper placement and dosage delivery for local gynecological treatment. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HGD, regulated under 21 CFR 884.4520, within the Obstetrics/Gynecology specialty. No special risk flags apply.

    View on FDA
    510(k)s
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HGD
    Device Class
    FDA class 1
    Regulation Number
    884.4520
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K823517 THE KLINE APPLICATOR

    FEI Numbers

    This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.