Cleared Traditional

K914280 - ECHOSIGHT STENT SET

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

K914280 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
23d faster than avg
Panel avg: 130d · This submission: 107d
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 69
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K914280.
AQ HYDROPHILIC STENT
K961446 · Cook Urological, Inc. · May 1996
SLIP-COAT STENTS
K930731 · Cook Urological, Inc. · Dec 1994
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
BARD(R) URETERAL STENT W/SUTURE
K883561 · C.R. Bard, Inc. · Nov 1988