C-FLEX URETERAL STENTS— 510(k) K991219

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K991219 for C-FLEX URETERAL STENTS, Substantially Equivalent on 1999-06-21. Applicant: Applied Medical Resources.

Clearance details

Applicant: Applied Medical Resources
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 1999-04-12
Decision date: 1999-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.