Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5895](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5895) → EXD — Irrigator, Ostomy

# EXD · Irrigator, Ostomy

_Gastroenterology, Urology · 21 CFR 876.5895 · Class 2_

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

## Overview

- **Product Code:** EXD
- **Device Name:** Irrigator, Ostomy
- **Regulation:** [21 CFR 876.5895](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5895)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

An ostomy irrigator is a device that consists of a container for fluid, tubing with a cone-shaped tip or a soft and flexible catheter with a retention shield and that is used to wash out the colon through a colostomy, a surgically created opening of the colon on the surface of the body.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K121833](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K121833.md) | OSTOMY IRRIGATION SET | Coloplast A/S | Jul 16, 2012 | SESE |
| [K914692](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K914692.md) | URINARY DIVERSION EVACUATING CATHETER | Cook Urological, Inc. | Jul 2, 1992 | SESE |
| [K904586](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K904586.md) | PALEX IRRIGATION SET | Palex Intl. SA | Dec 28, 1990 | SESE |
| [K871791](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K871791.md) | BLOXOM IRRIGATOR | I.B. Bloxom C/O Hogan & Hartson | May 20, 1987 | SESE |
| [K840268](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K840268.md) | IRRIGATION SYSTEM | Coloplast A/S | Apr 5, 1984 | SESE |
| [K832299](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K832299.md) | VISI-FLOW IRRIGATOR | Convatec, A Division of E.R. Squibb & Sons | Aug 26, 1983 | SESE |
| [K823274](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K823274.md) | UNI-TIP COLOSTOMY IRRIGATION CONE | Howmedica Corp. | Dec 7, 1982 | SESE |
| [K811160](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K811160.md) | SUR-FIT IRRIGATION SLEEVE | E. R. Squibb & Sons, Inc. | Jun 2, 1981 | SESE |
| [K790749](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K790749.md) | COLOSTOMY ENEMA DEVICE | Vabar Corp. | May 16, 1979 | SESE |
| [K790750](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K790750.md) | COLOSTOMY DEVICE W/ PRESSURE LID | Vabar Corp. | May 14, 1979 | SESE |
| [K770251](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K770251.md) | SUPER X ADJUSTRETTE | Qualitone | Feb 28, 1977 | SESE |
| [K760810](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K760810.md) | TUBE, GASTRO-ENTEROSTOMY | Sherwood Medical Industries | Feb 28, 1977 | SESE |

## Top Applicants

- Coloplast A/S — 2 clearances
- Vabar Corp. — 2 clearances
- Convatec, A Division of E.R. Squibb & Sons — 1 clearance
- Cook Urological, Inc. — 1 clearance
- E. R. Squibb & Sons, Inc. — 1 clearance

---

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

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