510(k) Report

Devices descending from K021343

18 later devices reach Isoseeds I-125 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103319I-SEEDTheragenics Corp.20110—
+1K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp.20059—
+1K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH200414—
+1K033781Bebig Isoseed I-125Bebig Isotopen-Und Medizintechnik GmbH20031—
+2K140849IsoseedEckert & Ziegler Bebig GmbH20140—
+2K113210Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC20121—
+2K091117Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model IaslbkaIsoaid, LLC20090—
+2K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp.200701
+2K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc.20067—
+2K053595Curay Custom Seed ArrayBiolucent, Inc.20060—
+3K242818IsoSphereIsoaid, LLC20250—
+3K092458Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18…Isoray Medical, Inc.20091—
+3K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc.20094—
+4K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.20200—
+4K180515GammaTileIsoray Medical, Inc.20183—
+5K190296GammaTileGt Medical Technologies20192—
+6K190839GammaTileGt Medical Technologies20201—
+7K221539GammaTileGt Medical Technologies20220—