Boston Scientific Corporation - FDA 510(k) Cleared Devices
Recent clearances: SpaceOAR Flex™ System, LithoVue Elite Digital Flexible Ureteroscope System, Navigator™ Flex Ureteral Access Sheath Set
239
Total
226
Cleared
1
Denied
FDA 510(k) Regulatory Record - Boston Scientific Corporation Gastroenterology & Urology ✕
102 devices
Cleared
Aug 26, 2026
LithoVue Elite Digital Flexible Ureteroscope System
Gastroenterology & Urology
140d
Cleared
Aug 04, 2026
Navigator™ Flex Ureteral Access Sheath Set
Gastroenterology & Urology
56d
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
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