BEUDAMED
    Product Code: HFK FDA class 2 21 CFR 884.3900

    Mold, Vaginal

    Obstetrics/Gynecology

    The Vaginal Mold is a device used to maintain the shape of the vaginal canal, typically following vaginal reconstructive surgery, to prevent contraction and adhesion formation during the healing process. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFK, 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
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    HFK
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K920838 MEDSURG CIRCUMCISION TRAY