Universa Firm Ureteral Stents and Stent Sets— 510(k) K161236

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K161236 for Universa Firm Ureteral Stents and Stent Sets, Substantially Equivalent on 2017-01-27. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2016-05-02
Decision date: 2017-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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.