510(k) Report

Devices descending from K051124

6 later devices reach Zilver 635 Biliary Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163169Zilver 518TM Biliary Stent; Zilver 635TM Biliary StentCook Ireland, Ltd.20171—
+1K163018Zilver 635 Biliary StentCook Ireland, Ltd.20163—
+2K182980Zilver 518 Biliary Stent, Zilver 635 Biliary StentCook Ireland, Ltd.20180—
+2K171809Epic Biliary Endoscopic Stent SystemBoston Scientific Corporation20172—
+3K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific20241—
+4K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific20240—