BEUDAMED
    Product Code: HEC FDA class 1 21 CFR 884.5920

    Insufflator, Vaginal

    Obstetrics/Gynecology

    The Vaginal Insufflator is a device used to introduce air or gas into the vaginal cavity, typically to facilitate gynecological examination or therapeutic procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from the 510(k) premarket notification requirement. The product code is HEC, regulated under 21 CFR 884.5920, within the Obstetrics/Gynecology specialty. No special risk flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HEC
    Device Class
    FDA class 1
    Regulation Number
    884.5920
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.