510(k) Report

Devices descending from K162906

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Convatec Limited20191—
+2K243228Flexi-Seal AIR (with ENFit Connector)Convatec20250—