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

Clearance details

Applicant

Cook Incorporated

Product code

Code FAD

Device class

Class 2

Regulation

21 CFR 876.4620

Advisory panel

Gastroenterology, Urology

Date received

2016-05-02

Decision date

2017-01-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bloomington, IN, US

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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 →

• Z-2971-2020 — Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladderClass II·Terminated·Cook Inc.·20200730

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161236.