Cleared Traditional

K875038 - MENTOR UNISTENT URETERAL STENT SET

K875038 is the FDA 510(k) clearance for MENTOR UNISTENT 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 87-day FDA review.

K875038 · Mentor Corp. · Gastroenterology & Urology device
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Mar 1988
Decision
87d
Days
Class 2
Risk

K875038 is an FDA 510(k) clearance for the MENTOR UNISTENT 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 March 3, 1988 after a review of 87 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 K875038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date March 03, 1988
Days to Decision 87 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: 130d · This submission: 87d
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 K875038.
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · C.R. Bard, Inc. · Apr 1991
BARD(R) URETERAL STENT W/SUTURE
K883561 · C.R. Bard, Inc. · Nov 1988
PORGES URETERAL STENT
K881744 · Bivona Medical Technologies · May 1988
MENTOR BLACK LIGHT URETERAL STENT SET
K873557 · Mentor Corp. · Feb 1988
KAMINSKY COMBINATION STENT & INJECTION CATHETER
K865085 · Van-Tec, Inc. · Mar 1987
SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE
K862539 · Mentor Corp. · Sep 1986