510(k) Report

Devices descending from K172493

2 later devices reach EnsoETM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233357EsoCool Thermal Regulation CatheterNuvaira, Inc.20240—
+1K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical20180—