Cleared Traditional

K961904 - AQ HYDROPHILIC DILATORS

K961904 is the FDA 510(k) clearance for AQ HYDROPHILIC DILATORS by Cook Urological, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOE) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K961904 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
155d
Days
Class 2
Risk

K961904 is an FDA 510(k) clearance for the AQ HYDROPHILIC DILATORS. Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 155 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5520 - 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 K961904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date October 18, 1996
Days to Decision 155 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
25d slower than avg
Panel avg: 130d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOE Dilator, Urethral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5520
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 - KOE Dilator, Urethral

All 13
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K961904.
Optilume Basic Urological Balloon Dilation Catheter
K191061 · Urotronic, Inc. · Jan 2020
120 FR OPTILUME PROSTATE BALLOON DILATOR
K920551 · American Medical Systems, Inc. · Oct 1992
DOWD(TM) II
K922349 · Boston Scientific Corp · Aug 1992
ENTRAC URETHRAL BALLOON DILATATION CATHETER
K920711 · American Medical Systems, Inc. · May 1992
AMS OPTILUME INFLATION SYRINGE
K900760 · American Medical Systems, Inc. · May 1990
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
K900761 · American Medical Systems, Inc. · May 1990