Cleared Traditional

K840059 - SILITEK URINARY DIVERSION STENT

K840059 is an FDA 510(k) clearance for SILITEK URINARY DIVERSION STENT, manufactured by Surgitek. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K840059 · Surgitek · Gastroenterology & Urology device
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Feb 1984
Decision
26d
Days
Class 2
Risk

K840059 is an FDA 510(k) clearance for the SILITEK URINARY DIVERSION STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Surgitek (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 26 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 Surgitek devices

FDA 510(k) Submission Details - K840059

510(k) Number K840059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1984
Decision Date February 04, 1984
Days to Decision 26 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
105d faster than avg
Panel avg: 131d · This submission: 26d
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 97
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K840059.
MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL-
K850176 · Mentor Corp. · Feb 1985
SURGITEK ALL SILICONE INFECTION DOUBJ
K833782 · Surgitek · Apr 1984
URETERAL DOUBLE PIGTAIL STENT
K834401 · Hobbs Medical, Inc. · Mar 1984
URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN
K832915 · Surgitek · Oct 1983
SURGITEK PERCUTANEOUS ARNEGRADE SILITEK
K831857 · Medical Engineering Corp. · Aug 1983
BARD URETERAL STENT
K823487 · C.R. Bard, Inc. · May 1983