Cleared Traditional

K072293 - FOSSA URETERAL OPEN STENTS

K072293 is an FDA 510(k) clearance for FOSSA URETERAL OPEN STENTS, manufactured by Fossa Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K072293 · Fossa Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
356d
Days
Class 2
Risk

K072293 is an FDA 510(k) clearance for the FOSSA URETERAL OPEN STENTS. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Fossa Medical, Inc. (Boston, US). The FDA issued a Cleared decision on August 6, 2008 after a review of 356 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fossa Medical, Inc. devices

FDA 510(k) Submission Details - K072293

510(k) Number K072293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2007
Decision Date August 06, 2008
Days to Decision 356 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
226d slower than avg
Panel avg: 130d · This submission: 356d
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 K072293.
Ultrathane Endoureterotomy Stent Set
K160891 · Cook Incorporated · Jun 2016
Universa Soft Ureteral Stents and Stent Sets
K151051 · Cook Incorporated · Jan 2016
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
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