MESH URETERAL STENT— 510(k) K011264

Substantially Equivalent

Applied Medical Resources Corp.

FDA 510(k) clearance K011264 for MESH URETERAL STENT, Substantially Equivalent on 2001-07-17. Applicant: Applied Medical Resources Corp..

Clearance details

Applicant: Applied Medical Resources Corp.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2001-04-25
Decision date: 2001-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, 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.