Cleared Special

K031292 - MODIFICATION TO FOSSA URETERAL STONE SW...

K031292 is an FDA 510(k) clearance for MODIFICATION TO FOSSA URETERAL STONE SW..., manufactured by Fossa Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Special 510(k) pathway after a 29-day FDA review.

K031292 · Fossa Medical, Inc. · Gastroenterology & Urology device
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May 2003
Decision
29d
Days
Class 2
Risk

K031292 is an FDA 510(k) clearance for the MODIFICATION TO FOSSA URETERAL STONE SWEEPER. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Fossa Medical, Inc. (Ayer, US). The FDA issued a Cleared decision on May 22, 2003 after a review of 29 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 Fossa Medical, Inc. devices

FDA 510(k) Submission Details - K031292

510(k) Number K031292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2003
Decision Date May 22, 2003
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
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 K031292.
PEDIATRIC URETERAL STENT
K060673 · Applied Medical Resources Corp. · Mar 2006
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
K043193 · C.R. Bard, Inc. · Dec 2004
MODIFICATION TO URETERAL STENT
K040760 · Applied Medical Resources Corp. · Oct 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
URETERAL STENT
K013784 · Boston Scientific Corp · Aug 2002