Cleared Traditional

K191609 - Tria Soft Ureteral Stent

K191609 is the FDA 510(k) clearance for Tria Soft Ureteral Stent by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K191609 · Boston Scientific Corporation · Gastroenterology & Urology device
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Aug 2019
Decision
60d
Days
Class 2
Risk

K191609 is an FDA 510(k) clearance for the Tria Soft Ureteral Stent. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on August 16, 2019 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K191609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2019
Decision Date August 16, 2019
Days to Decision 60 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
70d faster than avg
Panel avg: 130d · This submission: 60d
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 75
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K191609.
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
Tria Firm Ureteral Stent
K190603 · Boston Scientific Corporation · May 2019
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
K181971 · Cook Incorporated · Apr 2019
Greene Renal Transplant Stent Set
K180557 · Cook Incorporated · Nov 2018