Boston Scientific - FDA 510(k) Cleared Devices
Recent clearances: OptiCross Coronary Imaging Catheter (H749518110), Orca Air/Water and Suction Valves, Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
58
Total
52
Cleared
1
Denied
FDA 510(k) Regulatory Record - Boston Scientific Gastroenterology & Urology ✕
21 devices
Cleared
Oct 09, 2025
Orca Air/Water and Suction Valves
Gastroenterology & Urology
27d
Cleared
Jul 03, 2025
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
Gastroenterology & Urology
69d
Cleared
Dec 06, 2024
WallFlex Biliary PLUS RX Stent System
Gastroenterology & Urology
74d
Cleared
Aug 30, 2024
WallFlex Biliary RX Stent System
Gastroenterology & Urology
196d
Cleared
Apr 29, 2024
Ultraflex Esophageal NG Stent System
Gastroenterology & Urology
137d
Cleared
Nov 28, 2023
Gold Probe Bipolar Electrohemostasis Catheter
Gastroenterology & Urology
90d
Cleared
Apr 28, 2021
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse...
Gastroenterology & Urology
30d
Cleared
Sep 28, 2018
ORISE Gel
Gastroenterology & Urology
262d
Cleared
CT
Apr 19, 2018
Embozene Color-Advanced Microspheres
Gastroenterology & Urology
93d
Cleared
Feb 09, 2018
ORISE Tissue Retractor System
Gastroenterology & Urology
101d
Cleared
Oct 27, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
Gastroenterology & Urology
28d
Cleared
Jan 30, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
Gastroenterology & Urology
90d