Cleared Traditional

K170531 - Ureteral Dilators and Percutaneous Neph...

K170531 is the FDA 510(k) clearance for Ureteral Dilators and Percutaneous Neph... by Coloplast Corp.. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K170531 · Coloplast Corp. · Gastroenterology & Urology device
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Aug 2017
Decision
176d
Days
Class 2
Risk

K170531 is an FDA 510(k) clearance for the Ureteral Dilators and Percutaneous Nephrostomy Dilators. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on August 17, 2017 after a review of 176 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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 Coloplast Corp. devices

Submission Details

510(k) Number K170531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2017
Decision Date August 17, 2017
Days to Decision 176 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
46d slower than avg
Panel avg: 130d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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 - EZN Dilator, Catheter, Ureteral

All 38
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K170531.
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COOK URETERAL BALLOON DILATION CATHETER SET
K040127 · Cook Urological, Inc. · Apr 2004