BEUDAMED
    Product Code: HGS FDA class 2 21 CFR 884.2700

    Catheter, Intrauterine And Introducer

    Obstetrics/Gynecology

    The Intrauterine Catheter and Introducer is a system used to place a pressure-sensing or fluid-delivery catheter inside the uterine cavity during labor, typically for direct intrauterine pressure measurement or amnioinfusion. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGS, regulated under 21 CFR 884.2700, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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

    Basic Information

    Product Code
    HGS
    Device Class
    FDA class 2
    Regulation Number
    884.2700
    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
    K914387 TRANSCERVICAL INTRAUTERINE KIT
    K905812 INTRAUTERINE CATHETER SET

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.