Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5270](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5270) → EZW — Stimulator, Electrical, Implantable, For Incontinence

# EZW · Stimulator, Electrical, Implantable, For Incontinence

_Gastroenterology, Urology · 21 CFR 876.5270 · Class 3_

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

## Overview

- **Product Code:** EZW
- **Device Name:** Stimulator, Electrical, Implantable, For Incontinence
- **Regulation:** [21 CFR 876.5270](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5270)
- **Device Class:** 3
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)
- **Implant:** yes

## Identification

An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P240031](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZW/P240031.md) | Neuspera Sacral Neuromodulation System | Neuspera Medical, Inc. | Jun 17, 2025 | APPR |
| [P170001](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZW/P170001.md) | VIRTIS SACRAL NEUROMODULATION SYSTEM | Cirtec Medical Corporation | Jan 11, 2023 | APPR |
| [P180046](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZW/P180046.md) | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Nov 13, 2019 | APPR |
| [P970004](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZW/P970004.md) | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL | Medtronic Neuromodulation | Sep 29, 1997 | APPR |

## Top Applicants

- Boston Scientific Corporation — 1 clearance
- Cirtec Medical Corporation — 1 clearance
- Medtronic Neuromodulation — 1 clearance
- Neuspera Medical, Inc. — 1 clearance

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

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