← Product Code [FCE](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FCE) · K900848

# ENEMA KIT 'STRAIGHT' DESIGN (K900848)

_Custom Medical Products, Ltd. · FCE · Apr 13, 1990 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FCE/K900848

## Device Facts

- **Applicant:** Custom Medical Products, Ltd.
- **Product Code:** [FCE](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FCE.md)
- **Decision Date:** Apr 13, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5210
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system (§ 876.5220).

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FCE/K900848](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FCE/K900848)

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