BEUDAMED
    Product Code: HDX FDA class 2 21 CFR 884.3900

    Dilator, Vaginal

    Obstetrics/Gynecology

    The Vaginal Dilator is a gynecological instrument used to gradually stretch or widen the vaginal canal, typically for therapeutic purposes such as treating vaginal stenosis or in preparation for procedures. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HDX, regulated under 21 CFR 884.3900, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    9
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    6
    Years Active
    24

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    Basic Information

    Product Code
    HDX
    Device Class
    FDA class 2
    Regulation Number
    884.3900
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    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 9 510(k) clearances via K numbers.

    K Number Device Name
    K241748 Intimate Rose Vaginal Dilators
    K233689 Hope&Her Vaginal Dilators
    K222492 Hope&Her Vaginal Dilators
    K231430 Intimate Rose Vaginal Dilators
    K220035 Milli Vaginal Dilator
    K211959 Milli Vaginal Dilator
    K130273 PANPAC VAGINAL DILATORS
    K071754 NEO-VAGINA SURGERY SET AND ACCESSORIES
    K003380 BIOTEQUE VAGINAL DILATOR

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.