Cleared Traditional

K163399 - Tria Firm Ureteral Stent

K163399 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 Traditional 510(k) pathway after a 199-day FDA review.

K163399 · Boston Scientific Corporation · Gastroenterology & Urology device
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Jun 2017
Decision
199d
Days
Class 2
Risk

K163399 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 June 22, 2017 after a review of 199 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 K163399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2016
Decision Date June 22, 2017
Days to Decision 199 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
69d slower than avg
Panel avg: 130d · This submission: 199d
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 K163399.
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
K170362 · Coloplast Corp. · Nov 2017
BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
K170422 · Coloplast Corp. · Nov 2017
Salle Intraoperative Pyeloplasty Stent Set
K170010 · Cook Incorporated · Aug 2017
Kwart Retro-Inject Ureteral Stent
K162109 · Cook Incorporated · Jun 2017
C-Flex Ureteral Stent Set
K162104 · Cook Incorporated · Apr 2017
Universa Firm Ureteral Stents and Stent Sets
K161236 · Cook Incorporated · Jan 2017