AQ HYDROPHILIC UROLOGICAL CATHETERS

K962004 · Cook Urological, Inc. · EYB · Jun 11, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962004
• Device Name: AQ HYDROPHILIC UROLOGICAL CATHETERS
• Applicant: Cook Urological, Inc.
• Product Code: EYB · Gastroenterology, Urology
• Decision Date: Jun 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram.

Device Story

AQ Hydrophilic Urological Catheters; used for drainage, irrigation, or retrograde pyelogram. Device consists of polyurethane, polyethylene, and vinyl catheter body with hydrophilic coating. Coating becomes lubricious upon hydration to reduce friction during insertion. Used in clinical settings by urologists or trained medical staff. Output is physical access to urinary tract for fluid management or diagnostic imaging. Benefits include reduced friction and improved patient comfort during catheterization.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through design, material, and process similarity to predicate devices.

Technological Characteristics

Materials: polyurethane, polyethylene, vinyl, hydrophilic coating. Function: lubricious surface via hydration to reduce friction. Sterilization: standard procedures consistent with existing marketed devices.

Indications for Use

Indicated for patients requiring urological drainage, irrigation, or retrograde pyelogram procedures.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Slip-Coat™ Catheters (Cook Incorporated)
• Uncoated urological catheters (Cook Urological)

Submission Summary (Full Text)

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K962004
8
JUN 11 1996

510(k) Premarket Notification
AQ Hydrophilic Catheters
Cook Urological

## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitted By:

Tammy Bacon
Cook Urological
1100 West Morgan Street
Spencer, Indiana 47460
[phone]
May 21, 1996

### Device

Trade Name: AQ Hydrophilic Urological Catheters

Proposed Classification Name: Catheter, Urological
Catheter, Ureteral, Gastro-Urology

### Predicate Devices:

The AQ Hydrophilic Urological Catheters are substantially equivalent to predicate devices in terms of indications for use, design, and materials of construction. Predicate devices include the Slip-Coat™ Catheters manufactured by Cook Incorporated and uncoated urological catheters manufactured by Cook Urological.

### Device Description:

The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram. Materials that comprise these devices are polurethane, polyethylene, vinyl and hydrophilic coating. The hydrophilic coating will allow the catheters to become lubricious which will reduce friction.

### Substantial Equivalence:

These devices will be manufactured according to specified process controls and a Quality Assurance Program. These devices will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510(k) substantial equivalence.