510(k) Report

Devices descending from K183120

7 later devices reach EmboCube Embolization Gelatin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240873TEMBO Embolic SystemInstylla, Inc.20241—
+1K213385GEMObsidio, Inc.20223Class I
+1K192480Torpedo Gelatin FoamBiosphere Medical, S.A.20190—
+2K253677Tembo Embolic SystemInstylla, Inc.20250—
+2K242507OBSIDIO™ Conformable EmbolicBoston Scientific20242—
+3K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation20260—
+3K253376OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation20250—