URETERAL ACCESS SET— 510(k) K896385

Substantially Equivalent

Applied Urology, Inc.

FDA 510(k) clearance K896385 for URETERAL ACCESS SET, Substantially Equivalent on 1990-01-22. Applicant: Applied Urology, Inc..

Clearance details

Applicant: Applied Urology, Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-06
Decision date: 1990-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.