Cleared Traditional

K903345 - BARD LUBRICIOUS - COATED URETERAL STENT...

K903345 is the FDA 510(k) clearance for BARD LUBRICIOUS - COATED URETERAL STENT... by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K903345 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Apr 1991
Decision
279d
Days
Class 2
Risk

K903345 is an FDA 510(k) clearance for the BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE. 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 April 30, 1991 after a review of 279 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. 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. Standard predicate reliance. 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K903345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1990
Decision Date April 30, 1991
Days to Decision 279 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 130d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K903345.
UROLOGICAL CATHETER & ACCESSORIES
K930882 · Applied Medical Resources · Jul 1993
ECHOSIGHT STENT SET
K914280 · Cook Urological, Inc. · Jan 1992
MENTOR BLACK LIGHT INJECTION STENT SET
K912060 · Mentor Corp. · Sep 1991
BARD(R) URETERAL STENT W/SUTURE
K883561 · C.R. Bard, Inc. · Nov 1988
PORGES URETERAL STENT
K881744 · Bivona Medical Technologies · May 1988
MENTOR UNISTENT URETERAL STENT SET
K875038 · Mentor Corp. · Mar 1988