510(k) Report

Devices descending from K801748

21 later devices reach 3M I-125 Seeds in Absorbable Carrier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982226Uromed Brachytheraphy Iodine-125 SourcesUromed Corp.199920—
+2K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH200414—
+2K021343Isoseeds I-125Bebig Isotopen-Und Medizintechnik GmbH200218—
+2K993552Isoseed PD-103Bebig Isotopentechnik GmbH20000—
+3K113210Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC20121—
+3K103319I-SEEDTheragenics Corp.20110—
+3K091117Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model IaslbkaIsoaid, LLC20090—
+3K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp.200701
+3K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc.20067—
+3K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp.20059—
+3K033781Bebig Isoseed I-125Bebig Isotopen-Und Medizintechnik GmbH20031—
+4K242818IsoSphereIsoaid, LLC20250—
+4K140849IsoseedEckert & Ziegler Bebig GmbH20140—
+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—
+4K053595Curay Custom Seed ArrayBiolucent, Inc.20060—
+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—