510(k) K043418— COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH

Substantially Equivalent

Cook Urological, Inc.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2004-12-13
Decision date: 2005-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.