Cleared Traditional

K851870 - MENTOR UNIVERSAL URETERAL STENT SET

K851870 is the FDA 510(k) clearance for MENTOR UNIVERSAL URETERAL STENT SET by Mentor Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K851870 · Mentor Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
64d
Days
Class 2
Risk

K851870 is an FDA 510(k) clearance for the MENTOR UNIVERSAL URETERAL STENT SET. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on July 2, 1985 after a review of 64 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

Submission Details

510(k) Number K851870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1985
Decision Date July 02, 1985
Days to Decision 64 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
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 77
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K851870.
MENTOR SINGLE COIL URINARY DIVERSION STENT SET
K860055 · Mentor Corp. · Mar 1986
CURITY URETERAL STENT
K854862 · The Kendal Co. · Feb 1986
URETERAL STENT
K852389 · American Medical Systems, Inc. · Sep 1985
MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S
K850175 · Mentor Corp. · Mar 1985
MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL-
K850176 · Mentor Corp. · Feb 1985
BARD URETERAL STENT
K823487 · C.R. Bard, Inc. · May 1983