510(k) Report

Devices descending from K011155

11 later devices reach Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc.20067—
+1K041702EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)Ibt SA20048—
+1K023073Seed LinkImplant Sciences Corp.20031—
+2K092458Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18…Isoray Medical, Inc.20091—
+2K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc.20094—
+2K053595Curay Custom Seed ArrayBiolucent, Inc.20060—
+3K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.20200—
+3K180515GammaTileIsoray Medical, Inc.20183—
+4K190296GammaTileGt Medical Technologies20192—
+5K190839GammaTileGt Medical Technologies20201—
+6K221539GammaTileGt Medical Technologies20220—