Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5365](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5365) → PRQ — Esophageal Dilator Kit

# PRQ · Esophageal Dilator Kit

_Gastroenterology, Urology · 21 CFR 876.5365 · Class 2_

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

## Overview

- **Product Code:** PRQ
- **Device Name:** Esophageal Dilator Kit
- **Regulation:** [21 CFR 876.5365](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5365)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

## Classification Rationale

Class II (special 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.

## Special Controls

*Classification.* Class II (special 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 (0 of 0)

_No cleared devices on record._

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

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