← Product Code [FCD](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FCD) · K864835

# TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* (K864835)

_Eisai U.S.A., Inc. · FCD · Feb 11, 1987 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/FCD/K864835

## Device Facts

- **Applicant:** Eisai U.S.A., Inc.
- **Product Code:** [FCD](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FCD.md)
- **Decision Date:** Feb 11, 1987
- **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).

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/FCD/K864835](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/FCD/K864835)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com