Cleared Special

K030503 - MODIFICATION TO CONTOUR POLARIS URETERAL STENT

K030503 is an FDA 510(k) clearance for MODIFICATION TO CONTOUR POLARIS URETERA..., manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Special 510(k) pathway after a 26-day FDA review.

K030503 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
26d
Days
Class 2
Risk

K030503 is an FDA 510(k) clearance for the MODIFICATION TO CONTOUR POLARIS URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 17, 2003 after a review of 26 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. 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.

FDA 510(k) Submission Details - K030503

510(k) Number K030503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date March 17, 2003
Days to Decision 26 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 131d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 121
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K030503.
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
K043193 · C.R. Bard, Inc. · Dec 2004
MODIFICATION TO URETERAL STENT
K040760 · Applied Medical Resources Corp. · Oct 2004
MODIFICATION TO FOSSA URETERAL STONE SWEEPER
K031292 · Fossa Medical, Inc. · May 2003
BARD ER URETERAL STENT WITH SUTURE
K022447 · C.R. Bard, Inc. · Jan 2003
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
K013921 · Porges S.A. · Oct 2002
URETERAL STENT
K013784 · Boston Scientific Corp · Aug 2002
K030503 · MODIFICATION TO CONTOUR POLARIS URETERAL STENT
Download PDF FDA Summary Boston Scientific Corp