Cleared Traditional

K201436 - Vortek Single Loop Ureteral Stent

K201436 is the FDA 510(k) clearance for Vortek Single Loop Ureteral Stent by Coloplast Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K201436 · Coloplast Corp. · Gastroenterology & Urology device
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Feb 2021
Decision
269d
Days
Class 2
Risk

K201436 is an FDA 510(k) clearance for the Vortek Single Loop Ureteral Stent. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on February 25, 2021 after a review of 269 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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 K201436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2020
Decision Date February 25, 2021
Days to Decision 269 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
139d slower than avg
Panel avg: 130d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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 - FAD Stent, Ureteral

All 74
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K201436.
NovoFlow Reinforced Ureteral Stent
K213186 · Coloplast Corp. · Feb 2022
JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
K212868 · Rocamed Sam · Jan 2022
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
K200260 · Boston Scientific Corporation · Apr 2021
Ureteral Stent Systems, Biliary Drainage Catheters
K191446 · Boston Scientific Corporation · Jan 2020
Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip
K190659 · Allwin Medical Devices, Inc. · Dec 2019
Dornier Ureteral Stent
K190312 · Dornier Medtech America, Inc. · Nov 2019