510(k) Report

Devices descending from K813269

3 later devices reach Two Piece Ostomy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140938Ostom-I Alert11 Health and Technologies, LLC20142—
+2K252140Heylo™ SystemColoplast Corp.20250—
+2K181643SmartBag (SmartPouch)11 Health Technologies Limited20180—