510(k) Report

Devices descending from K061231

10 later devices reach Wellflex Biliary RX Stent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121430Evolution Biliary Stent SystemCook Ireland, Ltd.20130—
+1K122072Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered)…Boston Scientific Corporation20124—
+1K112543Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic…Boston Scientific Corporation20115—
+1K083374Wallflex Biliary RX Partially-Covered Stent SystemBoston Scientific Corp20096—
+1K083627Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520…Boston Scientific Corporation20096—
+1K08173310MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890Boston Scientific Corp20087—
+2K140630Wallflex Biliary RX Stent SystemBoston Scientific201431
+3K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific20241—
+3K223469WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation20231—
+4K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific20240—