BEUDAMED
    Product Code: HHJ FDA class 2 21 CFR 884.2225

    Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic

    Obstetrics/Gynecology

    The Obstetric-Gynecologic Ultrasonic Intracorporeal Device Locator is a device using ultrasound imaging to locate and confirm the position of devices placed within the uterus or pelvis, such as intrauterine contraceptive devices or other implants. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHJ, regulated under 21 CFR 884.2225, 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
    HHJ
    Device Class
    FDA class 2
    Regulation Number
    884.2225
    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
    K023227 USG 2000SA