Cleared Traditional

K082805 - PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIA...

K082805 is an FDA 510(k) clearance for PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIA..., manufactured by Q Urological Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 483-day FDA review.

K082805 · Q Urological Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
483d
Days
Class 2
Risk

K082805 is an FDA 510(k) clearance for the PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Q Urological Corporation (Natick, US). The FDA issued a Cleared decision on January 20, 2010 after a review of 483 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Q Urological Corporation devices

FDA 510(k) Submission Details - K082805

510(k) Number K082805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2008
Decision Date January 20, 2010
Days to Decision 483 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 130d · This submission: 483d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAD Device Classification - Class 2, Special Controls

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 94
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K082805.
Ultrathane Endoureterotomy Stent Set
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K141344 · Boston Scientific Corp · Oct 2014
RESONANCE METALLIC URETERAL STENT
K063742 · Cook Ireland, Ltd. · May 2007
PEDIATRIC URETERAL STENT
K060673 · Applied Medical Resources Corp. · Mar 2006
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
K043193 · C.R. Bard, Inc. · Dec 2004