510(k) Report

Devices descending from K010340

12 later devices reach Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc.20082—
+1K053640IntegraDirex Systems Corp.20066—
+1K023535Tripter X-1 Compact DuetDirex Systems Corp.200310—
+1K013471Delta 2000 Series Extracorporeal LithotripterE.S.W.L. Products, Inc.20020—
+2K252913Break WaveSonomotion, Inc.20261—
+2K111947Duet MagnaDirex Systems Corp.20120—
+2K062147Integra SLDirex Systems Corp.20063—
+2K061873VERT-XDirex Systems Corp.20060—
+2K050091Tripter-X1 Compact Duet SP (Separated Pulse)Direx Systems Corp.20050—
+2K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp.20048—
+2K040470Tripter X-1 CompactDirex Systems Corp.20049—
+3K261086Break WaveSonomotion, Inc.20260—