Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System— 510(k) K233939

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K233939 for Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System, Substantially Equivalent on 2024-04-29. Applicant: Boston Scientific.

Clearance details

Applicant: Boston Scientific
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 2023-12-14
Decision date: 2024-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marborough, MA, US

Download summary PDF View on FDA.gov ↗

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.