510(k) Report

Devices descending from K181300

9 later devices reach Embosphere Microspheres through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250971Embosphere MicrospheresBiosphere Medical, S.A.20250—
+1K183120EmboCube Embolization GelatinBiosphere Medical, S.A.20197—
+2K240873TEMBO Embolic SystemInstylla, Inc.20241—
+2K213385GEMObsidio, Inc.20223Class I
+2K192480Torpedo Gelatin FoamBiosphere Medical, S.A.20190—
+3K253677Tembo Embolic SystemInstylla, Inc.20250—
+3K242507OBSIDIO™ Conformable EmbolicBoston Scientific20242—
+4K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation20260—
+4K253376OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation20250—