Cleared Special

K172289 - pAguaMedicina PERSISTENT Structural Hyd...

K172289 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 65-day FDA review.

K172289 · Q Urological Corporation · Gastroenterology & Urology device
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Oct 2017
Decision
65d
Days
Class 2
Risk

K172289 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 October 4, 2017 after a review of 65 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 - K172289

510(k) Number K172289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2017
Decision Date October 04, 2017
Days to Decision 65 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
65d faster than avg
Panel avg: 130d · This submission: 65d
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 K172289.
VORTEK URETERAL DOUBLE LOOP STENT
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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
Tria Firm Ureteral Stent
K163399 · Boston Scientific Corporation · Jun 2017
Kwart Retro-Inject Ureteral Stent
K162109 · Cook Incorporated · Jun 2017