Boston Scientific Corporation - FDA 510(k) Cleared Devices
Recent clearances: OBSIDIO Conformable Embolic, FARADRIVE™ Steerable Sheath (M004PF21M402), TheraSphere 360™ Y-90 Management Platform
236
Total
223
Cleared
1
Denied
FDA 510(k) Regulatory Record - Boston Scientific Corporation Gastroenterology & Urology ✕
100 devices
Cleared
Jul 10, 2026
WallFlex Esophageal Stent System
Gastroenterology & Urology
28d
Cleared
Jun 17, 2026
RIVOS™ EUS Access Device (M00553900)
Gastroenterology & Urology
127d
Cleared
May 18, 2026
MOSES Raydar™
Gastroenterology & Urology
125d
Cleared
Sep 24, 2025
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with...
Gastroenterology & Urology
28d
Cleared
Jul 09, 2025
Flexiva Pulse Laser Fiber
Gastroenterology & Urology
30d
Cleared
Jun 11, 2025
Rezum System
Gastroenterology & Urology
104d
Cleared
Apr 15, 2025
Percuflex Ureteral Stent
Gastroenterology & Urology
28d
Cleared
Mar 21, 2025
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)
Gastroenterology & Urology
28d
Cleared
Feb 06, 2025
Resolution Clip (M00522600)
Gastroenterology & Urology
27d
Cleared
Nov 15, 2024
AdVance™ XP Male Sling System (720163-03)
Gastroenterology & Urology
51d
Cleared
Jul 01, 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with...
Gastroenterology & Urology
27d
Cleared
Apr 04, 2024
Agile Esophageal Stent System
Gastroenterology & Urology
122d
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