FLEXIBLE URETERONEPHROSOCOPE— 510(k) K924135

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K924135 for FLEXIBLE URETERONEPHROSOCOPE, Substantially Equivalent on 1993-04-14. Applicant: Applied Medical Resources.

Clearance details

Applicant: Applied Medical Resources
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 1992-08-18
Decision date: 1993-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.