510(k) Report

Devices descending from K011106

15 later devices reach Stonelith, Model V5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061350Lithodiamond UltraPck Electronic Industry & Trade Co., Ltd.20060—
+1K030346Twinheads TH-101 Extracorporeal Shock Wave LithotripterFmd, LLC20033—
+1K023535Tripter X-1 Compact DuetDirex Systems Corp.200310—
+2K111947Duet MagnaDirex Systems Corp.20120—
+2K111808Sonolith I-MoveEdap Tms France20110—
+2K050091Tripter-X1 Compact Duet SP (Separated Pulse)Direx Systems Corp.20050—
+2K042561Twinheads TH-103 Extracorporeal Shock Wave LithotripterFmd, LLC20040—
+2K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp.20048—
+2K040470Tripter X-1 CompactDirex Systems Corp.20049—
+3K062147Integra SLDirex Systems Corp.20063—
+3K053640IntegraDirex Systems Corp.20066—
+4K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc.20082—
+4K061873VERT-XDirex Systems Corp.20060—
+5K252913Break WaveSonomotion, Inc.20261—
+6K261086Break WaveSonomotion, Inc.20260—