BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Jada System (Jada-2002)

    K Number: K253642 · Decision May 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    177

    Basic Information

    Device Name
    Jada System (Jada-2002)
    K Number
    K253642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Organon, LLC
    Date Received
    November 19, 2025
    Decision Date
    May 15, 2026
    Product Code
    OQY
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OQY Intrauterine Tamponade Balloon

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OQY), ordered by most recent decision date.

    ELLAVI UBT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Bakri Essential Postpartum Balloon

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Jada System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Jada System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all