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) → PSJ — Rectal Dilator Kit

# PSJ · Rectal Dilator Kit

_Gastroenterology, Urology · 21 CFR 876.5450 · Class 1_

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

## Overview

- **Product Code:** PSJ
- **Device Name:** Rectal Dilator Kit
- **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 (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/PSJ](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/PSJ)

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