Cleared Traditional

K903345 - BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE

K903345 is an FDA 510(k) clearance for BARD LUBRICIOUS - COATED URETERAL STENT..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with 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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Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K903345

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
148d slower than avg
Panel avg: 131d · This submission: 279d
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 121
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K903345.
SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT
K913928 · Surgitek Medical Engineering Corp. · Nov 1991
MENTOR BLACK LIGHT INJECTION STENT SET
K912060 · Mentor Corp. · Sep 1991
NORTEC URETERAL STENT
K910691 · North American Sterilization & Packaging Co. · Aug 1991
VAS-CATH URETERAL STENTS CATHETER, MODIFICATION
K905505 · Vas-Cath, Inc. · Apr 1991
SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
K905289 · Medical Engineering Corp. · Mar 1991
MODEL OSP, SANDHILL AMS
K904231 · Sandhill Scientific, Inc. · Jan 1991
K903345 · BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
Download PDF C.R. Bard, Inc.