BEUDAMED
    Product Code: OQY FDA class 2 21 CFR 884.4530

    Intrauterine Tamponade Balloon

    Obstetrics/Gynecology

    The Intrauterine Tamponade Balloon (product code OQY) is an obstetric device designed to provide temporary control or reduction of postpartum uterine bleeding. It is inserted into the uterus and inflated to apply pressure against the uterine walls to manage hemorrhage following childbirth. As an FDA Class 2 device under regulation 884.4530, it requires 510(k) premarket clearance and falls within the Obstetrics/Gynecology specialty. The device is not flagged as an implant and is not life-sustaining.

    View on FDA
    510(k)s
    11
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    8
    Years Active
    16

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    Basic Information

    Product Code
    OQY
    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

    Definition

    provides temporary control or reduction of postpartum uterine bleeding

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K253642 Jada System (Jada-2002)
    K230849 ELLAVI UBT
    K223098 Bakri Essential Postpartum Balloon
    K212757 Jada System
    K201199 Jada System
    K191264 Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
    K170622 Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
    K153591 ebb Complete Tamponade System
    K150573 ebb Complete Tamponade System
    K101535 BT-CATH
    K091958 BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.