Cleared Traditional

K170531 - Ureteral Dilators and Percutaneous Nephrostomy Dilators (FDA 510(k) Clearance)

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

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
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 55
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K170531.
Optilume® High Pressure Urological Balloon Dilation Catheter
K250910 · Urotronic, Inc. · May 2025
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
K220781 · Allwin Medical Devices, Inc. · May 2023
In-Ka Ureteral Balloon Dilatation Catheter
K201007 · Coloplast Corp. · Jun 2020
EQUINOX Balloon Dilatation Catheter
K190612 · Dornier Medtech America, Inc. · Dec 2019