K183636

Substantially Equivalent

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

Applicant: Boston Scientific Corporation
Product code: FBN
Advisory panel: Gastroenterology, Urology
Date received: 2018-12-26
Decision date: 2019-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

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.