510(k) K920218— ESOPHAGEAL Z-STENT

Substantially Equivalent

Wilson-Cook Medical, Inc.

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 1992-01-16
Decision date: 1994-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, 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.