510(k) Report

Devices descending from K041582

8 later devices reach Modification to Tripter X-1 Compact Duet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111947Duet MagnaDirex Systems Corp.20120—
+1K062147Integra SLDirex Systems Corp.20063—
+1K053640IntegraDirex Systems Corp.20066—
+1K050091Tripter-X1 Compact Duet SP (Separated Pulse)Direx Systems Corp.20050—
+2K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc.20082—
+2K061873VERT-XDirex Systems Corp.20060—
+3K252913Break WaveSonomotion, Inc.20261—
+4K261086Break WaveSonomotion, Inc.20260—