← Product Code [KPH](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPH) · K813494

# WATERS ILEAL RESERVOIR CATHETER (K813494)

_Waters Instruments, Inc. · KPH · Dec 31, 1981 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPH/K813494

## Device Facts

- **Applicant:** Waters Instruments, Inc.
- **Product Code:** [KPH](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPH.md)
- **Decision Date:** Dec 31, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5030
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A continent ileostomy catheter is a flexible tubular device used as a form during surgery for continent ileostomy and it provides drainage after surgery. Additionally, the device may be inserted periodically by the patient for routine care to empty the ileal pouch. This generic type of device includes the rectal catheter for continent ileostomy.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPH/K813494](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPH/K813494)

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