Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5280](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5280) → EZY — Device, Incontinence, Mechanical/Hydraulic

# EZY · Device, Incontinence, Mechanical/Hydraulic

_Gastroenterology, Urology · 21 CFR 876.5280 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZY

## Overview

- **Product Code:** EZY
- **Device Name:** Device, Incontinence, Mechanical/Hydraulic
- **Regulation:** [21 CFR 876.5280](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5280)
- **Device Class:** 3
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)
- **Implant:** yes

## Identification

An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra. The totally implanted device may consist of a static pressure pad, or a system with a container of radiopaque fluid in the abdomen and a manual pump and valve under the skin surface that is connected by tubing to an adjustable pressure pad or to a cuff around the urethra. The fluid is pumped as needed from the container to inflate the pad or cuff to pass on the urethra.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P130018](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZY/P130018.md) | PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN | Uromedica, Inc. | Nov 24, 2015 | APPR |
| [P000053](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZY/P000053.md) | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | Jun 14, 2001 | APPR |

## Top Applicants

- Boston Scientific Corp — 1 clearance
- Uromedica, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZY](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZY)

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