510(k) Report

Devices descending from K090830

3 later devices reach Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp.20240—
+1K180214Repris Bladder Injection SystemUro-1, Inc.20181—
+2K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.20260—