510(k) Report

Devices descending from K180152

2 later devices reach gel-e Flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)Cresilon, Inc.20231—
+2K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.20250—