Cleared Traditional

K892855 - URETHRAL BALLOON DILATION CATHETER SET

K892855 is an FDA 510(k) clearance for URETHRAL BALLOON DILATION CATHETER SET, manufactured by Cook Urological, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOE cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K892855 · Cook Urological, Inc. · Gastroenterology & Urology device
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Nov 1989
Decision
213d
Days
Class 2
Risk

K892855 is an FDA 510(k) clearance for the URETHRAL BALLOON DILATION CATHETER SET. 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 November 17, 1989 after a review of 213 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

FDA 510(k) Submission Details - K892855

510(k) Number K892855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date November 17, 1989
Days to Decision 213 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 131d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOE Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K892855.
APEX(TM) PROSTATIC BALLOON DILATION CATHETER
K913477 · Peripheral Systems Group · Dec 1991
AMS OPTILUME INFLATION SYRINGE
K900760 · American Medical Systems, Inc. · May 1990
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
K900761 · American Medical Systems, Inc. · May 1990
PROSTATIC URETHRO. BALLOON DILATATION CATHETER
K873295 · Medi-Tech, Inc. · Jul 1989
VAN-TEC URETHRAL DILATATION SYSTEM
K870695 · Van-Tec, Inc. · Mar 1987
VAN-TEC MEATAL DILATOR
K851158 · Van-Tec, Inc. · Apr 1985