Cleared Special

FOSSA URETERAL OPEN LUMEN STENT (K033368) - FDA 510(k) Clearance

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

K033368 · Fossa Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
36d
Days
Class 2
Risk

K033368 is an FDA 510(k) clearance for the FOSSA URETERAL OPEN LUMEN STENT. Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Fossa Medical, Inc. (Boston, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 K033368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2003
Decision Date November 26, 2003
Days to Decision 36 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
94d faster than avg
Panel avg: 130d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EYB Catheter, Ureteral, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EYB Catheter, Ureteral, Gastro-urology

All 27
Devices cleared under the same product code (EYB) and FDA review panel - the closest regulatory comparables to K033368.
RocaTub Ureteral Catheter
K192183 · Promepal Sam · Apr 2020
Dornier MINNOW Ureteral Catheter
K191187 · Dornier Medtech America, Inc. · Sep 2019
UPJ Occlusion Balloon Catheter
K183323 · Cook Incorporated · Aug 2019
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
K182695 · Cook Incorporated · Jun 2019
Ureteric Catheters
K182122 · Coloplast Corp. · Oct 2018
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
K180182 · Cook Incorporated · Sep 2018