510(k) Report

Devices descending from K032734

14 later devices reach Convatec Fecal Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112342Flexi-Seal Signal Fecal Management SystemConvatec, Inc.20128—
+1K073598Bard Dignicare Stool Management SystemC.R. Bard, Inc.20085—
+2K150350Flexi-Seal Signal Fecal Management SystemConvatec, Ltd.20156—
+2K133251Bard Dignishield Stool Management SystemC.R. Bard, Inc.20140—
+2K102391Bard Dignishield Stool Management SystemC.R. Bard, Inc.20104—
+3K221400hygh-tec drainageCreative Balloons GmbH20231—
+3K193325Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement…Prosys International, Ltd.20200—
+3K162906Flexi-Seal PROTECT Fecal Management SystemConvatec20172—
+3K133465Consure Stool Management SystemConsure Medical Pvt, Ltd.20142—
+4K242336hygh-tec Drainage IIAmb Medtec20250—
+4K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Convatec Limited20191—
+4K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool…Consure Medical Pvt, Ltd.20161—
+5K243228Flexi-Seal AIR (with ENFit Connector)Convatec20250—
+5K212444Qora Stool Management KitCm Technologies, Inc.20210—