← Product Code [FAD](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD) · K961371

# SUBCUTANEOUS URINARY DIVERSON STENT SET (K961371)

_Cook Urological, Inc. · FAD · Jul 24, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD/K961371

## Device Facts

- **Applicant:** Cook Urological, Inc.
- **Product Code:** [FAD](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD.md)
- **Decision Date:** Jul 24, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4620
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## Intended Use

The Subcutaneous Urinary Diversion Stent Set and Exchange Set is used to create a new tunnel leading from the renal pelvis to the urinary bladder for the purpose of providing decompression of the renal system.

## Device Story

Device creates subcutaneous tunnel from renal pelvis to urinary bladder for renal decompression; set includes stent, dilators, sheaths, wire guides, needle, syringe; exchange set includes dilator, sheath, positioner, release sleeve, wire guide; intended for one-time use; operated by clinicians in surgical/urological settings; facilitates urinary drainage; provides therapeutic benefit by relieving renal system pressure.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Stent and accessory set; materials consistent with predicate devices; single-use; sterilization via standard procedures; mechanical construction.

## Regulatory Identification

A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.

## Submission Summary (Full Text)

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K961371
JUL 24 1996
17

510(k) Premarket Notification
Subcutaneous Urinary Diversion Stent Set
Cook Urological

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

### Submitted By:

Tammy Bacon
Cook Urological
1100 West Morgan Street
Spencer, Indiana 47460
(812) 829-4891
April 8, 1996

### Device

Trade Name: Subcutaneous Urinary Diversion Stent Set
Proposed Classification Name: Splint, Ureteral

### Predicate Devices:

The Subcutaneous Urinary Diversion Stent Set is comprised of a stent and accessories which are equivalent to predicate devices in terms of indications for use, design, and materials of construction.

### Device Description:

The Subcutaneous Urinary Diversion Stent Set and Exchange Set is used to create a new tunnel leading from the renal pelvis to the urinary bladder for the purpose of providing decompression of the renal system. The set contains a stent, dilators, sheaths, wire guides, needle syringe and the exchange set contains a dilator, sheath, positioner, release sleeve and wire guide. This device is intended for one-time use.

### Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological, Inc. This device is similar with respect to indications for use, materials, and physical construction to predicate devices, thereby meeting the requirements for section 510(k) substantial equivalency.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD/K961371](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD/K961371)

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