Cleared Traditional

K914280 - ECHOSIGHT STENT SET

K914280 is an FDA 510(k) clearance for ECHOSIGHT STENT SET, manufactured by Cook Urological, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K914280 · Cook Urological, Inc. · Gastroenterology & Urology device
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Jan 1992
Decision
107d
Days
Class 2
Risk

K914280 is an FDA 510(k) clearance for the ECHOSIGHT STENT SET. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on January 9, 1992 after a review of 107 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 Cook Urological, Inc. devices

FDA 510(k) Submission Details - K914280

510(k) Number K914280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1991
Decision Date January 09, 1992
Days to Decision 107 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
24d faster than avg
Panel avg: 131d · This submission: 107d
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 102
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K914280.
MENLO CARE AQUASTENT SET
K923394 · Menlo Care, Inc. · Nov 1993
URETERAL STENT
K930733 · Surgitek · Jul 1993
UROLOGICAL CATHETER & ACCESSORIES
K930882 · Applied Medical Resources · Jul 1993
MENTOR BLACK LIGHT INJECTION STENT SET
K912060 · Mentor Corp. · Sep 1991
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