Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5110](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5110) → PHS — Oral Airway Assist

# PHS · Oral Airway Assist

_Anesthesiology · 21 CFR 868.5110 · Class 1_

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

## Overview

- **Product Code:** PHS
- **Device Name:** Oral Airway Assist
- **Regulation:** [21 CFR 868.5110](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5110)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

## 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 § 868.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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