Cleared Special

MODIFICATION TO FOSSA URETERAL STONE SWEEPER (K031292) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031292 · Fossa Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 121
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K031292.
Disposable Ureteral Stents
K251890 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Feb 2026
Endura™ Ureteral Stent and Stent Set
K251469 · Cathegenix (Xiamen) Co., Ltd. · Dec 2025
Ureteral Stents (AF-D series)
K243039 · Alton (Shanghai) Medical Instruments Co., Ltd. · Jun 2025
Disposable ureteral stent
K243830 · Shenzhen Trious Medical Technology Co., Ltd. · May 2025
Percuflex Ureteral Stent
K250824 · Boston Scientific Corporation · Apr 2025
RELIEF™ Ureteral Stent Kit
K232920 · Ureteral Stent Company · Mar 2024