FDA 510(k) Applications for Medical Device Product Code: OQY (Intrauterine Tamponade Balloon)

FDA 510(k) Applications for Medical Device Product Code "OQY"
(Intrauterine Tamponade Balloon)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K201199	Alydia Health	Jada System	08/28/2020
K212757	Alydia Health	Jada System	09/30/2021
K150573	CLINICAL INNOVATIONS, LLC	ebb Complete Tamponade System	03/25/2015
K153591	CLINICAL INNOVATIONS, LLC	ebb Complete Tamponade System	01/14/2016
K223098	Cook Incorporated	Bakri Essential Postpartum Balloon	10/28/2022
K170622	Cook Incorporated	Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component	03/31/2017
K091958	GLENVEIGH SURGICAL, LLC	BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM	04/30/2010
K191264	Ujenzi Charitable Trust	Every Second Matters-Uterine Balloon Tamponade (ôESM-UBTö)	10/30/2019
K101535	UTAH MEDICAL PRODUCTS, INC.	BT-CATH	01/11/2011