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) → QON — Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

# QON · Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

_Gastroenterology, Urology · 21 CFR 876.5270 · Class 3_

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

## Overview

- **Product Code:** QON
- **Device Name:** Implanted Electrical Device Intended For Treatment Of Fecal 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P190006](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/QON/P190006.md) | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Sep 6, 2019 | APPR |
| [P080025](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/QON/P080025.md) | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM | Medtronic Neuromodulation | Mar 14, 2011 | APPR |

## Top Applicants

- Boston Scientific Corporation — 1 clearance
- Medtronic Neuromodulation — 1 clearance

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

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