Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5450](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5450) → FFP — Dilator, Rectal

# FFP · Dilator, Rectal

_Gastroenterology, Urology · 21 CFR 876.5450 · Class 1_

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

## Overview

- **Product Code:** FFP
- **Device Name:** Dilator, Rectal
- **Regulation:** [21 CFR 876.5450](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5450)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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.

## Classification Rationale

Class I (general 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.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K964634](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFP/K964634.md) | ANOKRYO | Mk Conquest Intl., Inc. | Jun 6, 1997 | SESE |
| [K901426](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFP/K901426.md) | COLONIC BALLOON DILATOR | Telemed Systems, Inc. | Jun 21, 1990 | SESE |
| [K894618](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFP/K894618.md) | INAMED RHEMO-D (TM) DILATOR | Inamed Development Co. | Jan 18, 1990 | SESE |
| [K884713](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFP/K884713.md) | COLONIC BALLOON DIALATORS | Primrose Medical, Inc. | Sep 29, 1989 | SESE |
| [K830354](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FFP/K830354.md) | COLORECTAL DILATOR | Cleveland Medical Supply & Services | May 27, 1983 | SESE |

## Top Applicants

- Cleveland Medical Supply & Services — 1 clearance
- Inamed Development Co. — 1 clearance
- Mk Conquest Intl., Inc. — 1 clearance
- Primrose Medical, Inc. — 1 clearance
- Telemed Systems, Inc. — 1 clearance

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

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