510(k) Report

Devices descending from K131206

5 later devices reach Cook Cervical Ripening Balloon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160664Aqueduct 100 Cervical DilatorGtimd, LLC20163—
+1K143424Utah CVX-RipeUtah Medical Products, Inc.20150—
+2K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC20210—
+2K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC20200—
+2K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical20190—