510(k) Report

Devices descending from K083153

7 later devices reach Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102391Bard Dignishield Stool Management SystemC.R. Bard, Inc.20104—
+1K100273Instaflo Bowel Catheter System KitHollister, Inc.20102—
+2K133465Consure Stool Management SystemConsure Medical Pvt, Ltd.20142—
+2K133251Bard Dignishield Stool Management SystemC.R. Bard, Inc.20140—
+2K123804Instaflo Bowel Catheter System KitHollister, Inc.20131—
+3K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool…Consure Medical Pvt, Ltd.20161—
+4K212444Qora Stool Management KitCm Technologies, Inc.20210—