510(k) Report

Devices descending from K043383

4 later devices reach N-DO Endoinjector Needle, Model PH00961109 and PH00961110 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd.200931
+2K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp.20240—
+2K180214Repris Bladder Injection SystemUro-1, Inc.20181—
+3K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.20260—