510(k) Report

Devices descending from K851144

4 later devices reach Ureteral Dilation Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180756Safety Wire Guide IntroducerCook Incorporated20180—
+1K180028Cook 810 Set, Desilets-Hoffman Introducer SetCook Incorporated20180—
+1K172527Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz…Cook Incorporated20171—
+2K213334Monarch Platform, UrologyAuris Health, Inc.202201