Cleared Traditional

K850175 - MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S

K850175 is an FDA 510(k) clearance for MENTOR DBL-COIL INDWELL. SILICONE URETE..., 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 49-day FDA review.

K850175 · Mentor Corp. · Gastroenterology & Urology device
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Mar 1985
Decision
49d
Days
Class 2
Risk

K850175 is an FDA 510(k) clearance for the MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on March 7, 1985 after a review of 49 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 - K850175

510(k) Number K850175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1985
Decision Date March 07, 1985
Days to Decision 49 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
82d faster than avg
Panel avg: 131d · This submission: 49d
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 K850175.
CURITY URETERAL STENT
K854862 · The Kendal Co. · Feb 1986
URETERAL STENT
K852389 · American Medical Systems, Inc. · Sep 1985
MENTOR UNIVERSAL URETERAL STENT SET
K851870 · Mentor Corp. · Jul 1985
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