510(k) Report

Devices descending from K880196

5 later devices reach Laminaria through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143447Dilapan-SMedicem Technology S.R.O20154—
+2K160664Aqueduct 100 Cervical DilatorGtimd, LLC20163—
+3K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC20210—
+3K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC20200—
+3K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical20190—