510(k) Report

Devices descending from K033761

24 later devices reach Gelspheres / Beadblock Compressible Microspheres through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K094018LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited20100—
+1K083091LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited20084—
+1K073417Embozene MicrospheresCelonova Biosciences, Inc.20086—
+1K042231Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited200417—
+2K152157LC Bead LUMIBiocompatibles UK, Ltd.20151—
+2K150958LifePearl MicroshperesMicroVention, Inc.201501
+2K141209Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Celonova Biosciences, Inc.20141—
+2K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc.20142—
+2K132675Embozene MicrospheresCelonova Biosciences, Inc.20134—
+2K130307Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Celonova Biosciences, Inc.20132—
+2K052742Hepasphere MicrospheresBiosphere Medical, Inc.200611—
+3K242794ONCOZENE MicrospheresVarian Medical Systems, Inc.20240—
+3K162373LC Bead LUMIBiocompatibles UK Limited20160—
+3K151187QuadraSphere MicrospheresBiosphere Medical, S.A.20150—
+3K113266Gel-Block Embolization PledgetsVascular Solutions, Inc.20128—
+3K113822Quadrasphere 30 to 60Biosphere Medical, Inc.20121—
+4K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+4K143038Gel-Block 10X embolization pledgetsVascular Solutions, Inc.20142—
+4K133237Gel-Bead Embolization SpheresVascular Solutions, Inc.20142—
+5K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+5K181021EmboCube Embolization GelatinBiosphere Medical, S.A.20181—
+5K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere…Vascular Solutions, Inc.20180—
+5K171946Gel-BeadVascular Solutions, Inc.20171—
+6K183578Torpedo Gelatin FoamBiosphere Medical, S.A.20190—