510(k) Report

Devices descending from K010621

27 later devices reach Accu-Space Absorbable Seeding Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131689Mri MarkerC4 Imaging, LLC20131—
+1K103449Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical20113—
+1K021311Synthetic Absorbable Seeding Spacers Made of Polydioxanone MaterialCp Medical20026—
+1K013975CP-SleeveCp Medical20026—
+1K013964Modification to Accu-Space Plain Gut Absorbable Seeding SpacersCp Medical200225—
+2K171487Sirius MRI Marker NSC4 Imaging, LLC20170—
+2K120859Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation20120—
+2K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp.200701
+2K034062CP Sleeve and River SleeveCp Medical20045—
+2K030594I-125 Rapid Strand, Model 7000Amersham Health200317—
+3K063177Rapid Strand RXOncura, Inc.200611
+3K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc.20067—
+3K061638Best Strand and Best SpacerBest Medical International, Inc.20060—
+3K053595Curay Custom Seed ArrayBiolucent, Inc.20060—
+3K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH200414—
+4K122764Rapid Strand RXMedi-Physics, Inc.20120—
+4K113210Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC20121—
+4K091117Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model IaslbkaIsoaid, LLC20090—
+4K092458Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18…Isoray Medical, Inc.20091—
+4K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc.20094—
+4K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp.20059—
+5K242818IsoSphereIsoaid, LLC20250—
+5K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.20200—
+5K180515GammaTileIsoray Medical, Inc.20183—
+6K190296GammaTileGt Medical Technologies20192—
+7K190839GammaTileGt Medical Technologies20201—
+8K221539GammaTileGt Medical Technologies20220—