Cleared Special

K981591 - VORTEK URETERAL DOUBLE LOOP STENT

K981591 is an FDA 510(k) clearance for VORTEK URETERAL DOUBLE LOOP STENT, manufactured by International Regulatory Consultants. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Special 510(k) pathway after a 158-day FDA review.

K981591 · International Regulatory Consultants · Gastroenterology & Urology device
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Oct 1998
Decision
158d
Days
Class 2
Risk

K981591 is an FDA 510(k) clearance for the VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by International Regulatory Consultants (Salt Lake City, US). The FDA issued a Cleared decision on October 9, 1998 after a review of 158 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all International Regulatory Consultants devices

FDA 510(k) Submission Details - K981591

510(k) Number K981591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date October 09, 1998
Days to Decision 158 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 130d · This submission: 158d
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 94
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K981591.
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
MODIFIED URETERAL INDWELLING CATHETER/STENT
K974541 · Boston Scientific Corp · Feb 1998
SUBCUTANEOUS URINARY DIVERSON STENT SET
K961371 · Cook Urological, Inc. · Jul 1996
LESE STENTS SETS
K952513 · Cook Urological, Inc. · Jun 1996