K091816

Substantially Equivalent

ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

Applicant: Boston Scientific Corporation
Product code: ESW
Advisory panel: General, Plastic Surgery
Date received: 2009-06-18
Decision date: 2009-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

Adverse events under product code ESW

product code ESW

Death: 11
Injury: 353
Malfunction: 442
Total: 806

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.