510(k) Report

Devices descending from K013597

14 later devices reach Tamponade Uterine Balloon Catheter Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101535BT-CathUtah Medical Products, Inc.20110—
+1K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC20102—
+1K062438Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn200611—
+1K060289Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01Frontline Medical20064—
+2K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated20176—
+2K150573ebb Complete Tamponade SystemClinical Innovations, LLC201511
+2K093904Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC20100—
+3K230849Ellavi UbtSinapi Biomedical (Pty), Ltd.20230—
+3K223098Bakri Essential Postpartum BalloonCook Incorporated20220—
+3K201199Jada SystemAlydia Health20202—
+3K191264Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)Ujenzi Charitable Trust20190—
+3K153591ebb Complete Tamponade SystemClinical Innovations, LLC20160—
+4K212757Jada SystemAlydia Health20211—
+5K253642Jada System (Jada-2002)Organon, LLC20260—