Hilzo Esophageal Stents— 510(k) K223266

Substantially Equivalent

Thoracent, Inc.

FDA 510(k) clearance K223266 for Hilzo Esophageal Stents, Substantially Equivalent on 2024-01-16. Applicant: Thoracent, Inc..

Clearance details

Applicant: Thoracent, Inc.
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 2022-10-24
Decision date: 2024-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington, NY, 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.