Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter— 510(k) K173657

Name: FDA 510(k) clearance K173657
Creator: U.S. Food and Drug Administration
Published: 2018-08-23

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K173657 for Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter, Substantially Equivalent on 2018-08-23. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2017-11-29
Decision date: 2018-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter)2025-06-16
K241424 — InnoCare Specialty Foley Catheter2024-09-18

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Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.