Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5800](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5800) → OGP — Cricothyrotomy Kit

# OGP · Cricothyrotomy Kit

_Anesthesiology · 21 CFR 868.5800 · Class 2_

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

## Overview

- **Product Code:** OGP
- **Device Name:** Cricothyrotomy Kit
- **Regulation:** [21 CFR 868.5800](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5800)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

## Classification Rationale

Class II.

## 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/OGP](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OGP)

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