Cleared Traditional

K191446 - Ureteral Stent Systems

K191446 is the FDA 510(k) clearance for Ureteral Stent Systems by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K191446 · Boston Scientific Corporation · Gastroenterology & Urology device
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Jan 2020
Decision
216d
Days
Class 2
Risk

K191446 is an FDA 510(k) clearance for the Ureteral Stent Systems, Biliary Drainage Catheters. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on January 2, 2020 after a review of 216 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K191446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 31, 2019
Decision Date January 02, 2020
Days to Decision 216 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
86d slower than avg
Panel avg: 130d · This submission: 216d
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 K191446.
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
Vortek Single Loop Ureteral Stent
K201436 · Coloplast Corp. · Feb 2021
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
Tria Soft Ureteral Stent
K191609 · Boston Scientific Corporation · Aug 2019