510(k) Report

Devices descending from K961923

203 later devices reach Berenstein Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991549Embosphere MicrospheresBiosphere Medical200052—
+1K964112Berenstein CoilTarget Therapeutics1997202—
+2K150870HydroPearl Microspheres, HydroPearl MicrospheresMicroVention, Inc.201501
+2K113266Gel-Block Embolization PledgetsVascular Solutions, Inc.20128—
+2K093813Occlusin 500 Artificial Embolization DeviceImbiotechnologies20100—
+2K052742Hepasphere MicrospheresBiosphere Medical, Inc.200611—
+2K050470Concentric Embolic PearlsConcentric Medical, Inc.20050—
+2K030966Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp2003181
+2K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationBiosphere Medical, Inc.200241—
+2K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics1997150—
+3K220567Easi-Vue embolic microspheres SystemAbk Biomedical, Inc.20221—
+3K181300Embosphere MicrospheresBiosphere Medical, S.A.201891
+3K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+3K150876Bead BlockBiocompatibles UK, Ltd.20164—
+3K151187QuadraSphere MicrospheresBiosphere Medical, S.A.20150—
+3K143038Gel-Block 10X embolization pledgetsVascular Solutions, Inc.20142—
+3K133237Gel-Bead Embolization SpheresVascular Solutions, Inc.20142—
+3K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc.20142—
+3K113822Quadrasphere 30 to 60Biosphere Medical, Inc.20121—
+3K100663Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321Boston Scientific Corporation20102—
+3K081768Cook Incorporated Polyvinyl Alcohol Foam Embolization ParticlesCook Incorporated20080—
+3K061790Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc.20061—
+3K034068Contour SE MicrospheresBoston Scientific Corp200410—
+3K033913ProgreatTerumo Medical Corp.20043—
+3K014041Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS…Cordis Neurovascular20020—
+3K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Boston Scientific, Target200098—
+3K993418Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilBoston Scientific, Target2000691
+3K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target2000105—
+3K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999138—
+4K250971Embosphere MicrospheresBiosphere Medical, S.A.20250—
+4K234123Easi-Vue® embolic microspheres SystemAbk Biomedical, Inc.20240—
+4K183120EmboCube Embolization GelatinBiosphere Medical, S.A.20197—
+4K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+4K181021EmboCube Embolization GelatinBiosphere Medical, S.A.20181—
+4K173871CalliSpheres Embolic Microspheres, 8Spheres Embolic MicrospheresSuzhou Hengrui Callisyn Biomedical Co., Ltd.20183—
+4K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere…Vascular Solutions, Inc.20180—
+4K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd.20181—
+4K171946Gel-BeadVascular Solutions, Inc.20171—
+4K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmCallisyn Biomedical, Inc.20170—
+4K141209Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Celonova Biosciences, Inc.20141—
+4K130259Bearing Nspva Embolization ParticlesMerit Medical Systems, Inc.20131—
+4K073417Embozene MicrospheresCelonova Biosciences, Inc.20086—
+4K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…Rj Medical, Inc.20080—
+4K042539GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilBoston Scientific Corp2004862
+4K033836Hydrocoil Embolic System (Hes)MicroVention, Inc.200367—
+4K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp.2002103—
+4K020434Microplex Coil System (MCS)MicroVention, Inc.200270—
+4K021494GDC Power Supply, Model GDC Power Supply: 451007-4Boston Scientific, Target200260—
+4K012145Microplex Coil SystemMicroVention, Inc.200196—
+5K250209Polyvinyl Alcohol Embolic MicrospheresCanyon Medical, Inc.20250—
+5K240873TEMBO Embolic SystemInstylla, Inc.20241—
+5K242794ONCOZENE MicrospheresVarian Medical Systems, Inc.20240—
+5K232934SunsphereHangzhou Yangshun Medical Technology Co.,Ltd20240—
+5K233813Bearing nsPVA Express™Merit Medical Systems, Inc.20230—
+5K213385GEMObsidio, Inc.20223Class I
+5K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd.20220—
+5K210562HRSpheres Narrow-Size Embolic MicrospheresSuzhou Hengrui Hongyuan Medical Co., Ltd.20210—
+5K192480Torpedo Gelatin FoamBiosphere Medical, S.A.20190—
+5K183578Torpedo Gelatin FoamBiosphere Medical, S.A.20190—
+5K132675Embozene MicrospheresCelonova Biosciences, Inc.20134—
+5K130307Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Celonova Biosciences, Inc.20132—
+5K103355GDC 360 Deteachable CoilBoston Scientific Corp2011163
+5K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp201058—
+5K092666Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250Boston Scientific Corp20090—
+5K080379Micrus Microcoil System, Deltapaq 10 Stretch ResistantMicrus Endovascular Corporation200810—
+5K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+5K063653Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation200735—
+5K062036Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation2006341
+5K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.20056516
+5K050700Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp2005591
+5K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.200466—
+5K033813Micrus Modified Microcoil System, CerecyteMicrus Corp.200440—
+5K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.200368—
+5K031578Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRMicrus Corp.200391—
+5K022735Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink…MicroVention, Inc.20020—
+5K021914Microplex Coil Systems (MCS)MicroVention, Inc.20021—
+6K253677Tembo Embolic SystemInstylla, Inc.20250—
+6K242507OBSIDIO™ Conformable EmbolicBoston Scientific20242—
+6K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+6K162373LC Bead LUMIBiocompatibles UK Limited20160—
+6K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+6K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+6K123338Barricade Embolization Coil SystemBlockade Medical201315—
+6K120850Target Detachable CoilStryker Neurovascular201201
+6K120274Deltamaxx 18 Microcoil SystemCodman and Shurtleff, Inc.20121—
+6K113412Target Detachable CoilStryker Neurovascular20111328
+6K112226Hydrocoil Embolic System (Hes)MicroVention, Inc.201121—
+6K112385Traget Detachable CoilStryker Neurovascular201115—
+6K103305Penumbra Embolization Coil SystemPenumbra, Inc.2011101
+6K103008Inzone Detachment SystemBoston Scientific Corp201021—
+6K102672Target Detachable CoilBoston Scientific Corp201016—
+6K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+6K091641Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)MicroVention, Inc.2009236
+6K090168Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415MicroVention, Inc.200918—
+6K090001V-Grip Plus Detachment Controller, Model VG503MicroVention, Inc.20090—
+6K083646Micrus Microcoli System, Deltaplush, Models CPL, DPLMicrus Endovascular Corporation200911
+6K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+6K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835—
+6K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.200834—
+6K080437Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDFMicrus Endovascular Corporation200810—