SpyGlass DS and DS II Direct Visualization System— 510(k) K181439

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K181439 for SpyGlass DS and DS II Direct Visualization System, Substantially Equivalent on 2018-08-23. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 2018-06-01
Decision date: 2018-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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.