BEUDAMED
    Product Code: HHO FDA class 2 21 CFR 884.4530

    Screw, Fibroid, Gynecological

    Obstetrics/Gynecology

    The Gynecological Fibroid Screw is a surgical instrument used during myomectomy procedures to grip and manipulate uterine fibroids (leiomyomas), allowing the surgeon to apply traction while excising fibroid tissue. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHO, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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    510(k)s
    2
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    0

    Basic Information

    Product Code
    HHO
    Device Class
    FDA class 2
    Regulation Number
    884.4530
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K915412 HYSTEROSCOPIC MYOMA SCREW
    K915388 LAPAROCOPIC MYOMA SCREW

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.