Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5900](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5900) → EZQ — Pouch, Colostomy

# EZQ · Pouch, Colostomy

_Gastroenterology, Urology · 21 CFR 876.5900 · Class 1_

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

## Overview

- **Product Code:** EZQ
- **Device Name:** Pouch, Colostomy
- **Regulation:** [21 CFR 876.5900](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5900)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K111365](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZQ/K111365.md) | VITALA CONTINENCE CONTROL DEVICE | Convatec, Inc. | Aug 19, 2011 | SESE |
| [K102536](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZQ/K102536.md) | VITALA CONTINENCE CONTROL DEVICE | Convatec, Inc. | Dec 1, 2010 | SESE |
| [K083785](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZQ/K083785.md) | VITALA CONTINENCE CONTROL DEVICE | Convatec | Apr 2, 2010 | SESE |
| [K922401](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZQ/K922401.md) | 4 SURE TM COLOSTOMY POUCH | Boston Pacific Medical, Inc. | Jun 10, 1992 | SESE |
| [K880327](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZQ/K880327.md) | MARLEN ULTRA ILEOSTOMY POUCH-5000 | Marlen Mfg. & Development Co. | Feb 19, 1988 | SESE |
| [K863830](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZQ/K863830.md) | CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM | Coloplast A/S | Oct 16, 1986 | SESE |

## Top Applicants

- Convatec, Inc. — 2 clearances
- Boston Pacific Medical, Inc. — 1 clearance
- Coloplast A/S — 1 clearance
- Convatec — 1 clearance
- Marlen Mfg. & Development Co. — 1 clearance

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

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