510(k) Report

Devices descending from K112342

8 later devices reach Flexi-Seal Signal Fecal Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150350Flexi-Seal Signal Fecal Management SystemConvatec, Ltd.20156—
+1K133251Bard Dignishield Stool Management SystemC.R. Bard, Inc.20140—
+2K221400hygh-tec drainageCreative Balloons GmbH20231—
+2K193325Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement…Prosys International, Ltd.20200—
+2K162906Flexi-Seal PROTECT Fecal Management SystemConvatec20172—
+3K242336hygh-tec Drainage IIAmb Medtec20250—
+3K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Convatec Limited20191—
+4K243228Flexi-Seal AIR (with ENFit Connector)Convatec20250—