510(k) Report

Devices descending from K170622

6 later devices reach Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230849Ellavi UbtSinapi Biomedical (Pty), Ltd.20230—
+1K223098Bakri Essential Postpartum BalloonCook Incorporated20220—
+1K201199Jada SystemAlydia Health20202—
+1K191264Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)Ujenzi Charitable Trust20190—
+2K212757Jada SystemAlydia Health20211—
+3K253642Jada System (Jada-2002)Organon, LLC20260—