LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000) +3 more— 510(k) K241598

Clearance details

Device name as filed

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500)

Applicant

Boston Scientific Corporation

Product code

Code FGB

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2024-06-04

Decision date

2024-07-01

Decision

Substantially Equivalent

Clearance type

Special

Location

Marlborough, MA, US

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• K261488 — OBSIDIO Conformable Embolic2026-07-24
• K262165 — FARADRIVE Steerable Sheath (M004PF21M402)2026-07-24
• K262462 — TheraSphere 360 Y-90 Management Platform2026-07-24

Death

6

Injury

552

Malfunction

3,922

Other

1

Total

4,481

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →