510(k) Report

Devices descending from K965147

17 later devices reach Biliary Stent, Biliary Stent System, Biliary Endoprosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101314Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp201014—
+1K101786Advanix Double Pigtail Biliary StentBoston Scientific Corp20101—
+2K203162Advanix Biliary Stent with NaviFlex RX Delivery SystemBoston Scientific Corporation20201—
+2K193600EndoGI Biliary Stent SystemEndogi Medical, Ltd.20203—
+2K181669ConvertX Biliary Stent SystemBrightwater Medical20190—
+2K140630Wallflex Biliary RX Stent SystemBoston Scientific201431
+2K133700Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and…Boston Scientific Corporation2014413
+3K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)20260—
+3K243412ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)20251—
+3K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific20241—
+3K232596EndoGI S-Path Biliary Stent SystemEndogi Medical, Ltd.20230—
+3K223469WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation20231—
+3K223592Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System…Boston Scientific Corporation202211
+3K202477EndoGI S-Path Biliary Stent SystemEndo GI Medical20202—
+4K251291Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System…Boston Scientific20250—
+4K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific20240—
+4K222627EndoGI S-Path Biliary Stent SystemEndo GI Medical20221—