510(k) Report

Devices descending from K160664

3 later devices reach Aqueduct 100 Cervical Dilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC20210—
+1K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC20200—
+1K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical20190—