Cleared Traditional

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter (K173657) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173657 · Cook Incorporated · Gastroenterology & Urology device
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Aug 2018
Decision
267d
Days
Class 2
Risk

K173657 is an FDA 510(k) clearance for the Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on August 23, 2018 after a review of 267 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Incorporated devices

Submission Details

510(k) Number K173657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2017
Decision Date August 23, 2018
Days to Decision 267 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 130d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZL Catheter, Retention Type, Balloon

All 45
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K173657.
PSM 3-Way Silicone Foley Catheter
K181616 · Pathway, LLC · Sep 2018
Bard Vertus Foley Catheter
K180781 · C.R. Bard, Inc. · Sep 2018
AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
K181814 · Amsino International, Inc. · Sep 2018
CystoSure Plus Catheter
K181346 · Emmy Medical, LLC · Aug 2018
Yikang Latex Foley Catheter
K173340 · Jiangxi Yikang Medical Instrument Group Co., Ltd. · Jul 2018
Silicone Foley Catheter for single use
K172807 · Changzhou Rongxin Medicine Minimal Invasion Technology · Jun 2018