510(k) K984068— FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS

Substantially Equivalent

Schneider (Europe) GmbH

Clearance details

Applicant: Schneider (Europe) GmbH
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 1998-11-16
Decision date: 1999-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bulach, SE

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.