Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath— 510(k) K172217

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K172217 for Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath, Substantially Equivalent on 2017-12-13. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2017-07-24
Decision date: 2017-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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.