Cleared Traditional

K021140 - FOSSA EXPANDING DOUBLE PIGTAIL URETERAL...

K021140 is an FDA 510(k) clearance for FOSSA EXPANDING DOUBLE PIGTAIL URETERAL..., manufactured by Fossa Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K021140 · Fossa Industries, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
80d
Days
Class 2
Risk

K021140 is an FDA 510(k) clearance for the FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Fossa Industries, Inc. (Boston, US). The FDA issued a Cleared decision on June 28, 2002 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fossa Industries, Inc. devices

FDA 510(k) Submission Details - K021140

510(k) Number K021140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2002
Decision Date June 28, 2002
Days to Decision 80 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
50d faster than avg
Panel avg: 130d · This submission: 80d
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 K021140.
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
MESH URETERAL STENT
K011264 · Applied Medical Resources Corp. · Jul 2001
CONTOUR POLARIS URETERAL STENT
K010002 · Boston Scientific Corp · Jan 2001
DD URETERAL STENT, INTEGRAL STENT
K982974 · Rusch Intl. · Jul 1999