Cleared Traditional

K823487 - BARD URETERAL STENT

K823487 is an FDA 510(k) clearance for BARD 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 185-day FDA review.

K823487 · C.R. Bard, Inc. · Gastroenterology & Urology device
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May 1983
Decision
185d
Days
Class 2
Risk

K823487 is an FDA 510(k) clearance for the BARD URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1983 after a review of 185 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

FDA 510(k) Submission Details - K823487

510(k) Number K823487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1982
Decision Date May 27, 1983
Days to Decision 185 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
54d slower than avg
Panel avg: 131d · This submission: 185d
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 K823487.
SILITEK URINARY DIVERSION STENT
K840059 · Surgitek · Feb 1984
URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN
K832915 · Surgitek · Oct 1983
SURGITEK PERCUTANEOUS ARNEGRADE SILITEK
K831857 · Medical Engineering Corp. · Aug 1983
SURGITEKS PERCUTANEOUS ANTEGRADE ALL -
K830884 · Medical Engineering Corp. · May 1983
URETERAL STANT SET
K820870 · Van-Tec, Inc. · Apr 1982
SURGITEK URINARY DIVERSION STENT
K800109 · Medical Engineering Corp. · Feb 1980