510(k) Report

Devices descending from K143038

2 later devices reach Gel-Block 10X embolization pledgets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181021EmboCube Embolization GelatinBiosphere Medical, S.A.20181—
+2K183578Torpedo Gelatin FoamBiosphere Medical, S.A.20190—