GORE-TEX PERITONEAL CATHETERR— 510(k) K820909

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K820909 for GORE-TEX PERITONEAL CATHETERR, Substantially Equivalent on 1982-05-21. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 1982-04-01
Decision date: 1982-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.