510(k) Report

Devices descending from K172614

1 later device reach Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara…Caldera Medical, Inc.20210—