510(k) Report

Devices descending from DEN160012

5 later devices reach D2 Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200167QuikClot Control+Z-Medica, LLC20203—
+1K183190NuStatBeeken Biomedical, LLC201901
+2K213198Ax-Surgi Surgical HemostatAdvamedica, Inc.20230—
+2K220971QuikClot Control+ Hemostatic DressingZ-Medica, LLC20221—
+3K243553QuikClot Control+ Hemostatic DeviceTeleflex Medical20250—