Cleared Abbreviated

K983498 - BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE

K983498 is an FDA 510(k) clearance for BARD INLAY LUBRICIOUS DOUBLE PIGTAIL UR..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Abbreviated 510(k) pathway after a 71-day FDA review.

K983498 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
71d
Days
Class 2
Risk

K983498 is an FDA 510(k) clearance for the BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER .... Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on December 15, 1998 after a review of 71 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K983498

510(k) Number K983498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1998
Decision Date December 15, 1998
Days to Decision 71 days
Submission Type Abbreviated
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
60d faster than avg
Panel avg: 131d · This submission: 71d
Pathway characteristics
Standards-based clearance path.

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 K983498.
UROSURGE SPIRALFLO URETERAL STENT
K992391 · Urosurge, Inc. · Aug 1999
DD URETERAL STENT, INTEGRAL STENT
K982974 · Rusch Intl. · Jul 1999
C-FLEX URETERAL STENTS
K991219 · Applied Medical Resources · Jun 1999
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
K981591 · International Regulatory Consultants · Oct 1998
UROSURGE SPIRASTENT PLUS URETERAL STENT
K981489 · Urosurge, Inc. · May 1998
UROSURGE FILASTENT URETERAL STENT
K981491 · Urosurge, Inc. · May 1998