Cleared Special

K033368 - FOSSA URETERAL OPEN LUMEN STENT

K033368 is an FDA 510(k) clearance for FOSSA URETERAL OPEN LUMEN STENT, manufactured by Fossa Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EYB cleared through the Special 510(k) pathway after a 36-day FDA review.

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

FDA 510(k) Submission Details - K033368

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.

EYB Device Classification - Class 2, Special Controls

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 21
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