LithoVue System— 510(k) K153049

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K153049 for LithoVue System, Substantially Equivalent on 2015-11-13. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2015-10-20
Decision date: 2015-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGB

product code FGB

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.