← Product Code [EXD](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD) · K811160

# SUR-FIT IRRIGATION SLEEVE (K811160)

_E. R. Squibb & Sons, Inc. · EXD · Jun 2, 1981 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K811160

## Device Facts

- **Applicant:** E. R. Squibb & Sons, Inc.
- **Product Code:** [EXD](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD.md)
- **Decision Date:** Jun 2, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5895
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K811160](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXD/K811160)

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