Cleared Special

K010002 - CONTOUR POLARIS URETERAL STENT

K010002 is the FDA 510(k) clearance for CONTOUR POLARIS URETERAL STENT by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Special 510(k) pathway after a 20-day FDA review.

K010002 · Boston Scientific Corp · Gastroenterology & Urology device
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Jan 2001
Decision
20d
Days
Class 2
Risk

K010002 is an FDA 510(k) clearance for the 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 January 22, 2001 after a review of 20 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.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K010002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2001
Decision Date January 22, 2001
Days to Decision 20 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
110d faster than avg
Panel avg: 130d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 74
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K010002.
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
DD URETERAL STENT, INTEGRAL STENT
K982974 · Rusch Intl. · Jul 1999
C-FLEX URETERAL STENTS
K991219 · Applied Medical Resources · Jun 1999
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE
K983498 · C.R. Bard, Inc. · Dec 1998