Home / Device Classification / OQY

OQY — Intrauterine Tamponade Balloon Class II

FDA Device Classification

Classification Details

Product Code
OQY
Device Class
Class II
Regulation Number
884.4530
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

provides temporary control or reduction of postpartum uterine bleeding

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230849sinapi biomedical (pty)ELLAVI UBTNovember 13, 2023
K223098cook incorporatedBakri Essential Postpartum BalloonOctober 28, 2022
K212757alydia healthJada SystemSeptember 30, 2021
K201199alydia healthJada SystemAugust 28, 2020
K191264ujenzi charitable trustEvery Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)October 30, 2019
K170622cook incorporatedBakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation CompoMarch 31, 2017
K153591clinical innovationsebb Complete Tamponade SystemJanuary 14, 2016
K150573clinical innovationsebb Complete Tamponade SystemMarch 25, 2015
K101535utah medical productsBT-CATHJanuary 11, 2011
K091958glenveigh surgicalBELFORT-DILDY OBSTETRIC TAMPONADE SYSTEMApril 30, 2010