510(k) K910691— NORTEC URETERAL STENT

Substantially Equivalent

North American Sterilization & Packaging Co.

Clearance details

Applicant: North American Sterilization & Packaging Co.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 1991-02-19
Decision date: 1991-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparta, NJ, US

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.