Intrauterine Tamponade Balloon

FDA product code OQY · Class II (moderate risk) · 21 CFR 884.4530 · Obstetrics/Gynecology

provides temporary control or reduction of postpartum uterine bleeding

11510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K253642Jada System (Jada-2002)OQY · Traditional Organon, LLC05/15/2026SE
K230849Ellavi UbtOQY · Traditional Sinapi Biomedical (Pty) , Ltd.11/13/2023SE
K223098Bakri Essential Postpartum BalloonOQY · Special Cook Incorporated10/28/2022SE
K212757Jada SystemOQY · Special Alydia Health09/30/2021SE
K201199Jada SystemOQY · Traditional Alydia Health08/28/2020SE
K191264Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)OQY · Traditional Ujenzi Charitable Trust10/30/2019SE
K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentOQY · Special Cook Incorporated03/31/2017SE
K153591ebb Complete Tamponade SystemOQY · Special Clinical Innovations, LLC01/14/2016SE
K150573ebb Complete Tamponade SystemOQY · Special Clinical Innovations, LLC03/25/2015SE
K101535Bt-CathOQY · Traditional Utah Medical Products, Inc.01/11/2011SE
K091958Belfort-Dildy Obstetric Tamponade SystemOQY · Traditional Glenveigh Surgical, LLC04/30/2010SE

Recalls

RecallProductFirmInitiated
Z-0123-2016 Class IIThe Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in…Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number… Clinical Innovations, LLC01/05/2015Terminated
Z-1014-2015 Class IIEbb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile…Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014. Clinical Innovations, LLC12/30/2014Terminated