510(k) Report

Devices descending from K150350

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221400hygh-tec drainageCreative Balloons GmbH20231—
+1K193325Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement…Prosys International, Ltd.20200—
+1K162906Flexi-Seal PROTECT Fecal Management SystemConvatec20172—
+2K242336hygh-tec Drainage IIAmb Medtec20250—
+2K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Convatec Limited20191—
+3K243228Flexi-Seal AIR (with ENFit Connector)Convatec20250—