510(k) Report

Devices descending from K021397

41 later devices reach Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220567Easi-Vue embolic microspheres SystemAbk Biomedical, Inc.20221—
+1K181300Embosphere MicrospheresBiosphere Medical, S.A.201891
+1K150876Bead BlockBiocompatibles UK, Ltd.20164—
+1K150870HydroPearl Microspheres, HydroPearl MicrospheresMicroVention, Inc.201501
+1K133237Gel-Bead Embolization SpheresVascular Solutions, Inc.20142—
+1K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc.20142—
+1K093813Occlusin 500 Artificial Embolization DeviceImbiotechnologies20100—
+1K081768Cook Incorporated Polyvinyl Alcohol Foam Embolization ParticlesCook Incorporated20080—
+1K061790Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc.20061—
+1K030966Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp2003181
+2K250971Embosphere MicrospheresBiosphere Medical, S.A.20250—
+2K234123Easi-Vue® embolic microspheres SystemAbk Biomedical, Inc.20240—
+2K183120EmboCube Embolization GelatinBiosphere Medical, S.A.20197—
+2K173871CalliSpheres Embolic Microspheres, 8Spheres Embolic MicrospheresSuzhou Hengrui Callisyn Biomedical Co., Ltd.20183—
+2K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere…Vascular Solutions, Inc.20180—
+2K171946Gel-BeadVascular Solutions, Inc.20171—
+2K141209Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Celonova Biosciences, Inc.20141—
+2K100663Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321Boston Scientific Corporation20102—
+2K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…Rj Medical, Inc.20080—
+2K034068Contour SE MicrospheresBoston Scientific Corp200410—
+2K033913ProgreatTerumo Medical Corp.20043—
+3K250209Polyvinyl Alcohol Embolic MicrospheresCanyon Medical, Inc.20250—
+3K240873TEMBO Embolic SystemInstylla, Inc.20241—
+3K242794ONCOZENE MicrospheresVarian Medical Systems, Inc.20240—
+3K232934SunsphereHangzhou Yangshun Medical Technology Co.,Ltd20240—
+3K213385GEMObsidio, Inc.20223Class I
+3K210562HRSpheres Narrow-Size Embolic MicrospheresSuzhou Hengrui Hongyuan Medical Co., Ltd.20210—
+3K192480Torpedo Gelatin FoamBiosphere Medical, S.A.20190—
+3K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd.20181—
+3K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmCallisyn Biomedical, Inc.20170—
+3K130259Bearing Nspva Embolization ParticlesMerit Medical Systems, Inc.20131—
+3K073417Embozene MicrospheresCelonova Biosciences, Inc.20086—
+4K253677Tembo Embolic SystemInstylla, Inc.20250—
+4K242507OBSIDIO™ Conformable EmbolicBoston Scientific20242—
+4K233813Bearing nsPVA Express™Merit Medical Systems, Inc.20230—
+4K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd.20220—
+4K132675Embozene MicrospheresCelonova Biosciences, Inc.20134—
+4K130307Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Celonova Biosciences, Inc.20132—
+5K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation20260—
+5K253376OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation20250—
+5K162373LC Bead LUMIBiocompatibles UK Limited20160—