510(k) Report

Devices descending from K042231

17 later devices reach Gelspheres Microspheres and Bead Block 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—
+1K052742Hepasphere MicrospheresBiosphere Medical, Inc.200611—
+2K152157LC Bead LUMIBiocompatibles UK, Ltd.20151—
+2K150958LifePearl MicroshperesMicroVention, Inc.201501
+2K151187QuadraSphere MicrospheresBiosphere Medical, S.A.20150—
+2K113266Gel-Block Embolization PledgetsVascular Solutions, Inc.20128—
+2K113822Quadrasphere 30 to 60Biosphere Medical, Inc.20121—
+3K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+3K162373LC Bead LUMIBiocompatibles UK Limited20160—
+3K143038Gel-Block 10X embolization pledgetsVascular Solutions, Inc.20142—
+3K133237Gel-Bead Embolization SpheresVascular Solutions, Inc.20142—
+4K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+4K181021EmboCube Embolization GelatinBiosphere Medical, S.A.20181—
+4K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere…Vascular Solutions, Inc.20180—
+4K171946Gel-BeadVascular Solutions, Inc.20171—
+5K183578Torpedo Gelatin FoamBiosphere Medical, S.A.20190—