Cleared Special

K163068 - pAguaMedicina PERSISTENT Structural Hyd...

K163068 is an FDA 510(k) clearance for pAguaMedicina PERSISTENT Structural Hyd..., manufactured by Q Urological Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Special 510(k) pathway after a 50-day FDA review.

K163068 · Q Urological Corporation · Gastroenterology & Urology device
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Dec 2016
Decision
50d
Days
Class 2
Risk

K163068 is an FDA 510(k) clearance for the pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Q Urological Corporation (Needham, US). The FDA issued a Cleared decision on December 22, 2016 after a review of 50 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 Q Urological Corporation devices

FDA 510(k) Submission Details - K163068

510(k) Number K163068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2016
Decision Date December 22, 2016
Days to Decision 50 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

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 K163068.
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EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
K141344 · Boston Scientific Corp · Oct 2014