Cleared Traditional

K912060 - MENTOR BLACK LIGHT INJECTION STENT SET

K912060 is an FDA 510(k) clearance for MENTOR BLACK LIGHT INJECTION STENT SET, 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 141-day FDA review.

K912060 · Mentor Corp. · Gastroenterology & Urology device
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Sep 1991
Decision
141d
Days
Class 2
Risk

K912060 is an FDA 510(k) clearance for the MENTOR BLACK LIGHT INJECTION 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 September 27, 1991 after a review of 141 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mentor Corp. devices

FDA 510(k) Submission Details - K912060

510(k) Number K912060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1991
Decision Date September 27, 1991
Days to Decision 141 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 131d · This submission: 141d
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 K912060.
URETERAL STENT
K930733 · Surgitek · Jul 1993
UROLOGICAL CATHETER & ACCESSORIES
K930882 · Applied Medical Resources · Jul 1993
ECHOSIGHT STENT SET
K914280 · Cook Urological, Inc. · Jan 1992
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · C.R. Bard, Inc. · Apr 1991
VAS-CATH URETERAL STENTS CATHETER, MODIFICATION
K905505 · Vas-Cath, Inc. · Apr 1991
SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
K905289 · Medical Engineering Corp. · Mar 1991