AQ HYDROPHILIC STENT— 510(k) K961446

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K961446 for AQ HYDROPHILIC STENT, Substantially Equivalent on 1996-05-28. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 1996-04-16
Decision date: 1996-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

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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.