Medical Device Manufacturer · US , Marlborough , MA

Boston Scientific Corporation - FDA 510(k) Cleared Devices

238 submissions · 225 cleared · Since 2005

Recent clearances: LithoVue Elite Digital Flexible Ureteroscope System, Navigator™ Flex Ureteral Access Sheath Set, OBSIDIO Conformable Embolic

Official Website

238

Total

225

Cleared

Denied

FDA 510(k) Regulatory Record - Boston Scientific Corporation Radiology ✕

6 devices

1-6 of 6

Cleared Jul 24, 2026

TheraSphere 360™ Y-90 Management Platform

K262462 · LLZ

Radiology · 7d

Cleared Mar 13, 2026

TheraSphere 360™ Y-90 Management Platform

K260479 · LLZ

Radiology · 28d

Cleared Feb 10, 2026

SpaceOAR Vue System (SV-2101)

K260119 · OVB

Radiology · 27d

Cleared Oct 28, 2025

TheraSphere 360™ Y-90 Management Platform

LumiCoil Platinum Fiducial Marker

K173251 · IYE

Radiology · 70d

Regulatory Intelligence

Linked clinical trials FDA-regulated device evidence

PCCP authorized FDA software change control pathway

Regulatory consultants 510(k) submission support ecosystem

Intertek Testing Services

Third Party Review Group, LLC

Boston Scientific

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 05, 2026

Boston Scientific Corporation - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Boston Scientific Corporation Radiology ✕

Filters