Cleared Traditional

K862539 - SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE

K862539 is an FDA 510(k) clearance for SILICONE DOUBLE COIL URETERAL STENT WIT..., manufactured by Mentor Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K862539 · Mentor Corp. · Gastroenterology & Urology device
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Sep 1986
Decision
69d
Days
Class 2
Risk

K862539 is an FDA 510(k) clearance for the SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on September 9, 1986 after a review of 69 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 Mentor Corp. devices

FDA 510(k) Submission Details - K862539

510(k) Number K862539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1986
Decision Date September 09, 1986
Days to Decision 69 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
62d faster than avg
Panel avg: 131d · This submission: 69d
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 106
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K862539.
KAMINSKY COMBINATION STENT & INJECTION CATHETER
K865085 · Van-Tec, Inc. · Mar 1987
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
BARD DOUBLE PIGTAIL URETERAL STENT
K861478 · C.R. Bard, Inc. · May 1986
MARDIS DANGLER URETERAL STENT SET
K860267 · Van-Tec, Inc. · Apr 1986
UROFLEX
K854908 · Angiomed U.S., Inc. · Mar 1986