510(k) Report

Devices descending from K101314

14 later devices reach Advanix Biliary Stent with Naviflex RX Delivery System through their predicates, nearest generation first.

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