Cleared Traditional

K170233 - Diposable Urinary Catheter (PVC Urinary...

K170233 is an FDA 510(k) clearance for Diposable Urinary Catheter (PVC Urinary..., manufactured by Zhanjiang Star Enterprise Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K170233 · Zhanjiang Star Enterprise Co., Ltd. · Gastroenterology & Urology device
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Oct 2017
Decision
261d
Days
Class 2
Risk

K170233 is an FDA 510(k) clearance for the Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, .... Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Zhanjiang Star Enterprise Co., Ltd. (Zhanjiang, CN). The FDA issued a Cleared decision on October 13, 2017 after a review of 261 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 Zhanjiang Star Enterprise Co., Ltd. devices

FDA 510(k) Submission Details - K170233

510(k) Number K170233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2017
Decision Date October 13, 2017
Days to Decision 261 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 130d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
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 - EZD Catheter, Straight

All 50
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K170233.
AMSure Hydrophilic Intermittent Catheter
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COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
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Medline Catheter Specimen Collector
K172541 · Medline Industries, Inc. · Feb 2018
Magic3 Go Intermittent Urinary Catheter
K172247 · C.R. Bard, Inc. · Sep 2017
Magic3 Go Intermittent Urinary Catheter
K150345 · C.R. Bard, Inc. · May 2015
Bard RiteCath Intermittent Urinary Catheter
K142575 · C.R. Bard, Inc. · Oct 2014