DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Cook Urological, Inc.
Product code
Code FAD
Device class
Class 2
Regulation
21 CFR 876.4620
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Spencer, IN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FAD

view all

More clearances from Cook Urological, Inc.

view all

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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K961446

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961446.

Data sourced from openFDA. This site is unofficial and independent of the FDA.