Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1925](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1925) → ETK — Tube, Toynbee Diagnostic

# ETK · Tube, Toynbee Diagnostic

_Ear, Nose, Throat · 21 CFR 874.1925 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETK

## Overview

- **Product Code:** ETK
- **Device Name:** Tube, Toynbee Diagnostic
- **Regulation:** [21 CFR 874.1925](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1925)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

The toynbee diagnostic tube is a listening device intended to determine the degree of openness of the eustachian tube.

## 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 § 874.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K823774](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETK/K823774.md) | WILSON EUSTACHIAN TUBAL, SONOGRAPH | Antares Technical Associates, Inc. | Jan 17, 1983 | SESE |

## Top Applicants

- Antares Technical Associates, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETK](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETK)

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