Cleared Traditional

K883561 - BARD(R) URETERAL STENT W/SUTURE

K883561 is an FDA 510(k) clearance for BARD URETERAL STENT W/SUTURE, 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 88-day FDA review.

K883561 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Nov 1988
Decision
88d
Days
Class 2
Risk

K883561 is an FDA 510(k) clearance for the BARD(R) URETERAL STENT W/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 November 15, 1988 after a review of 88 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 - K883561

510(k) Number K883561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1988
Decision Date November 15, 1988
Days to Decision 88 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
43d faster than avg
Panel avg: 131d · This submission: 88d
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 K883561.
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
VAS-CATH URETERAL STENT CATHETER
K894357 · Vas-Cath, Inc. · Oct 1989
PORGES URETERAL STENT
K881744 · Bivona Medical Technologies · May 1988
SURGITEK SUPER DOUBLE J URETERAL STENT KIT
K880660 · Surgitek · Apr 1988
MENTOR UNISTENT URETERAL STENT SET
K875038 · Mentor Corp. · Mar 1988