BEUDAMED
    Product Code: HGG FDA class 2 21 CFR 884.5070

    Controller, Abortion Unit, Vacuum

    Obstetrics/Gynecology

    The Vacuum Abortion Unit Controller is a component device that regulates and controls the vacuum pressure of a uterine aspiration system used in surgical abortion or miscarriage management procedures. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGG, regulated under 21 CFR 884.5070, 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
    —

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    Basic Information

    Product Code
    HGG
    Device Class
    FDA class 2
    Regulation Number
    884.5070
    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
    K883283 DISPOSABLE AMNIOTOME