Cleared Special

K190603 - Tria Firm Ureteral Stent

K190603 is the FDA 510(k) clearance for Tria Firm Ureteral Stent by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Special 510(k) pathway after a 77-day FDA review.

K190603 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
77d
Days
Class 2
Risk

K190603 is an FDA 510(k) clearance for the Tria Firm 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 May 24, 2019 after a review of 77 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K190603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2019
Decision Date May 24, 2019
Days to Decision 77 days
Submission Type Special
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
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

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 K190603.
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
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
K181971 · Cook Incorporated · Apr 2019
Greene Renal Transplant Stent Set
K180557 · Cook Incorporated · Nov 2018
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
K180469 · Coloplast Corp. · Nov 2018