510(k) Report

Devices descending from K172769

6 later devices reach CryOmega Flexx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203481CryoVIVERecensmedical, Inc.20215—
+2K230599TargetCool™Recensmedical, Inc.20232—
+2K220674TargetCoolRecensmedical, Inc.20224—
+3K253114TargetCool™ (RM-DT02W)Recensmedical, Inc.20250—
+3K253348TargetCool-eRecensmedical, Inc.20250—
+3K221234TargetCoolRecensmedical, Inc.20223—