← Product Code LJE · K961933

# CIRCLE NEPHROSTOMY CATHETER SET (K961933)

_Cook Urological, Inc. · LJE · Jul 18, 1996 · GU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K961933

## Device Facts

- **Applicant:** Cook Urological, Inc.
- **Product Code:** LJE
- **Decision Date:** Jul 18, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** GU
- **Attributes:** Therapeutic

## Intended Use

The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures.

## Device Story

Circle Nephrostomy Catheter Set; used for urinary diversion post-nephrostomy or nephroureterostomy; facilitates drainage in stenotic/obstructed UPJ cases; device consists of catheter set; used by clinicians in clinical settings; provides mechanical diversion of urine; benefits patient by relieving obstruction and preventing hydronephrosis.

## Clinical Evidence

Bench testing only. Biocompatibility testing performed on silicone components; results confirm compliance with requirements. Polyvinylchloride and polypropylene components do not contact body tissue.

## Technological Characteristics

Materials: silicone (patient-contacting), polyvinylchloride, and polypropylene (non-patient-contacting). Form factor: catheter set for urinary diversion. Sterilization: standard methods consistent with existing company products.

## Predicate Devices

- Silastic® U-Tube Nephrostomy Kit (Dow Corning Corporation)
- Circle Nephrostomy Tube (Mentor Urology)

## Submission Summary (Full Text)

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510(k) Premarket Notification
Circle Nephrostomy Catheter Set
Cook Urological, Incorporated

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

Submitted By:

Rick Lykins
Cook Urological, Incorporated
1100 West Morgan Street
Spencer, Indiana 47460
(812) 829-4891
May 16, 1996

K961933

JUL 18 1996

## Device:

Trade Name: Circle Nephrostomy Catheter Set

Proposed Classification Name: Catheter, Nephrostomy, General & Plastic Surgery 79 GBO

## Predicate Devices:

The Circle Nephrostomy Catheter Set is substantially equivalent to predicate circle nephrostomy catheter sets in terms of indications for use, design, construction and materials equivalence. Predicate devices include:

- Silastic® U-Tube Nephrostomy Kit manufactured by Dow Corning Corporation.
- Circle Nephrostomy Tube manufactured by Mentor Urology

## Device Description:

The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures. The materials used in this device are silicone, polyvinylchloride and polypropylene. Biocompatibility testing has been performed on the silicone. Results show the material to meet the requirements of these tests. The polyvinylchloride and polypropylene do not come into contact with body tissue.

## Substantial Equivalence:

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

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**Source:** [https://fda.innolitics.com/device/K961933](https://fda.innolitics.com/device/K961933)

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