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

Name: FDA 510(k) clearance K172217
Creator: U.S. Food and Drug Administration
Published: 2017-12-13

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. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
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 ↗

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K252572 — Prodeon Urethral Sheath System2025-10-07

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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.