Boston Scientific Corporation - FDA 510(k) Cleared Devices

Cleared Sep 24, 2025

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with...

K252703 · FGB

Gastroenterology & Urology · 28d

Cleared Jul 09, 2025

Flexiva Pulse Laser Fiber

K251759 · GEX

Gastroenterology & Urology · 30d

Cleared Jun 11, 2025

Rezum System

K250584 · KNS

Gastroenterology & Urology · 104d

Cleared Apr 15, 2025

Percuflex Ureteral Stent

K250824 · FAD

Gastroenterology & Urology · 28d

Cleared Mar 21, 2025

Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)

K250517 · FED

Gastroenterology & Urology · 28d

Cleared Feb 06, 2025

Resolution Clip (M00522600)

K250066 · PKL

Gastroenterology & Urology · 27d

Cleared Nov 15, 2024

AdVance™ XP Male Sling System (720163-03)

K242960 · OTM

Gastroenterology & Urology · 51d

Cleared Jul 01, 2024

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with...

K241598 · FGB

Gastroenterology & Urology · 27d

Cleared Apr 04, 2024

Agile Esophageal Stent System

K233837 · ESW

Gastroenterology & Urology · 122d

Cleared Mar 08, 2024

WallFlex Colonic Stent System with Anchor Lock Delivery System

K234046 · MQR

Gastroenterology & Urology · 78d

Cleared Dec 12, 2023

StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue...

K233645 · FGB

Gastroenterology & Urology · 28d

Cleared Oct 27, 2023

AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm)

K233318 · KNS

Gastroenterology & Urology · 28d