Cleared Traditional

PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X (K013921) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 121
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K013921.
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Endura™ Ureteral Stent and Stent Set
K251469 · Cathegenix (Xiamen) Co., Ltd. · Dec 2025
Ureteral Stents (AF-D series)
K243039 · Alton (Shanghai) Medical Instruments Co., Ltd. · Jun 2025
Disposable ureteral stent
K243830 · Shenzhen Trious Medical Technology Co., Ltd. · May 2025
Percuflex Ureteral Stent
K250824 · Boston Scientific Corporation · Apr 2025
RELIEF™ Ureteral Stent Kit
K232920 · Ureteral Stent Company · Mar 2024