Cleared Traditional

K013921 - PORGES SILICONE DOUBLE LOOP URETERAL STENT

K013921 is an FDA 510(k) clearance for PORGES SILICONE DOUBLE LOOP URETERAL STENT, manufactured by Porges S.A.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K013921 · Porges S.A. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
324d
Days
Class 2
Risk

K013921 is an FDA 510(k) clearance for the PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Porges S.A. (Le Plessis Robinson Cedex, FR). The FDA issued a Cleared decision on October 17, 2002 after a review of 324 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 Porges S.A. devices

FDA 510(k) Submission Details - K013921

510(k) Number K013921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2001
Decision Date October 17, 2002
Days to Decision 324 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
194d slower than avg
Panel avg: 130d · This submission: 324d
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 K013921.
MODIFICATION TO URETERAL STENT
K040760 · Applied Medical Resources Corp. · Oct 2004
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