Cleared Traditional

PEDIATRIC URETERAL STENT (K060673) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060673 · Applied Medical Resources Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2006
Decision
15d
Days
Class 2
Risk

K060673 is an FDA 510(k) clearance for the PEDIATRIC URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 15 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 Applied Medical Resources Corp. devices

Submission Details

510(k) Number K060673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2006
Decision Date March 29, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 47
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K060673.
Ultrathane Endoureterotomy Stent Set
K160891 · Cook Incorporated · Jun 2016
Universa Soft Ureteral Stents and Stent Sets
K151051 · Cook Incorporated · Jan 2016
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
K141344 · Boston Scientific Corp · Oct 2014
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
K043193 · C.R. Bard, Inc. · Dec 2004
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
K030503 · Boston Scientific Corp · Mar 2003
BARD ER URETERAL STENT WITH SUTURE
K022447 · C.R. Bard, Inc. · Jan 2003