← Product Code [FFP](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFP) · K901426

# COLONIC BALLOON DILATOR (K901426)

_Telemed Systems, Inc. · FFP · Jun 21, 1990 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFP/K901426

## Device Facts

- **Applicant:** Telemed Systems, Inc.
- **Product Code:** [FFP](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFP.md)
- **Decision Date:** Jun 21, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5450
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFP/K901426](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFP/K901426)

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