PEDIATRIC URETERAL STENT— 510(k) K060673

Name: FDA 510(k) clearance K060673
Creator: U.S. Food and Drug Administration
Published: 2006-03-29

Substantially Equivalent

Applied Medical Resources Corp.

FDA 510(k) clearance K060673 for PEDIATRIC URETERAL STENT, Substantially Equivalent on 2006-03-29. Applicant: Applied Medical Resources Corp.. Device class: 2.

Clearance details

Applicant: Applied Medical Resources Corp.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 2006-03-14
Decision date: 2006-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, CA, US

Download summary PDF View on FDA.gov ↗

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K250824 — Percuflex Ureteral Stent +11 more2025-04-15

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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.