510(k) Report

Devices descending from K090584

3 later devices reach Intrabeam System with Balloon Applicator and CBG Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+1K110590Intrabeam Needle ApplicatorCarl Zeiss Surgical GmbH201221
+2K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—