Cleared Traditional

K961446 - AQ HYDROPHILIC STENT

K961446 is an FDA 510(k) clearance for AQ HYDROPHILIC STENT, 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 42-day FDA review.

K961446 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
42d
Days
Class 2
Risk

K961446 is an FDA 510(k) clearance for the AQ HYDROPHILIC STENT. 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 May 28, 1996 after a review of 42 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 Cook Urological, Inc. devices

FDA 510(k) Submission Details - K961446

510(k) Number K961446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1996
Decision Date May 28, 1996
Days to Decision 42 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 131d · This submission: 42d
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 K961446.
UROSURGE UROSTENT
K973504 · Princeton Regulatory Assoc. · Jan 1998
SUBCUTANEOUS URINARY DIVERSON STENT SET
K961371 · Cook Urological, Inc. · Jul 1996
LESE STENTS SETS
K952513 · Cook Urological, Inc. · Jun 1996
CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT
K960148 · Cabot Medical Corp. · Mar 1996
QUADRA-COIL URETERAL STENT
K946296 · Surgitek · Mar 1995
SLIP-COAT STENTS
K930731 · Cook Urological, Inc. · Dec 1994