URETERAL DILATOR & URETERAL STONE DISLODGER— 510(k) K850954

Name: FDA 510(k) clearance K850954
Creator: U.S. Food and Drug Administration
Published: 1985-04-03

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K850954 for URETERAL DILATOR & URETERAL STONE DISLODGER, Substantially Equivalent on 1985-04-03. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code FFL
Device class: Class 2
Regulation: 21 CFR 876.4680
Advisory panel: Gastroenterology, Urology
Date received: 1985-03-08
Decision date: 1985-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

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.