Cleared Traditional

K982974 - DD URETERAL STENT, INTEGRAL STENT

K982974 is an FDA 510(k) clearance for DD URETERAL STENT, manufactured by Rusch Intl.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K982974 · Rusch Intl. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
311d
Days
Class 2
Risk

K982974 is an FDA 510(k) clearance for the DD URETERAL STENT, INTEGRAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on July 2, 1999 after a review of 311 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 Rusch Intl. devices

FDA 510(k) Submission Details - K982974

510(k) Number K982974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1998
Decision Date July 02, 1999
Days to Decision 311 days
Submission Type Traditional
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
180d slower than avg
Panel avg: 131d · This submission: 311d
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 104
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K982974.
MESH URETERAL STENT
K011264 · Applied Medical Resources Corp. · Jul 2001
CONTOUR POLARIS URETERAL STENT
K010002 · Boston Scientific Corp · Jan 2001
UROSURGE SPIRALFLO URETERAL STENT
K992391 · Urosurge, Inc. · Aug 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
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
K981591 · International Regulatory Consultants · Oct 1998