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

    BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM

    K Number: K091958 · Decision Apr 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    303

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
    K Number
    K091958
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Glenveigh Surgical, LLC
    Date Received
    July 1, 2009
    Decision Date
    April 30, 2010
    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.

    Jada System (Jada-2002)

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

    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
    View all

    Other Clearances by Glenveigh Surgical, LLC

    K Number Device Name
    K093904 GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER