510(k) Report

Devices descending from K021012

7 later devices reach Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040625Atad Ard CatheterAtad Developments, Ltd.20056—
+2K131206Cook Cervical Ripening BalloonCook, Inc.20135—
+3K160664Aqueduct 100 Cervical DilatorGtimd, LLC20163—
+3K143424Utah CVX-RipeUtah Medical Products, Inc.20150—
+4K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC20210—
+4K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC20200—
+4K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical20190—