Cleared Traditional

K861478 - BARD DOUBLE PIGTAIL URETERAL STENT

K861478 is an FDA 510(k) clearance for BARD DOUBLE PIGTAIL 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 23-day FDA review.

K861478 · C.R. Bard, Inc. · Gastroenterology & Urology device
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May 1986
Decision
23d
Days
Class 2
Risk

K861478 is an FDA 510(k) clearance for the BARD DOUBLE PIGTAIL URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on May 15, 1986 after a review of 23 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K861478

510(k) Number K861478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1986
Decision Date May 15, 1986
Days to Decision 23 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
108d faster than avg
Panel avg: 131d · This submission: 23d
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 K861478.
ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT
K864225 · Angiomed U.S., Inc. · Jan 1987
METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.
K863492 · Surgitek · Dec 1986
SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE
K862539 · Mentor Corp. · Sep 1986
MARDIS DANGLER URETERAL STENT SET
K860267 · Van-Tec, Inc. · Apr 1986
UROFLEX
K854908 · Angiomed U.S., Inc. · Mar 1986
MENTOR SINGLE COIL URINARY DIVERSION STENT SET
K860055 · Mentor Corp. · Mar 1986