# Various Aural Grommets

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/various-aural-grommets-etd>
- Manufacturer: [Exmoor Plastics Limited](https://devicerts.com/manufacturers/exmoor-plastics-limited) (United Kingdom)
- Name in the registry: VARIOUS AURAL GROMMETS
- Device class: Class II (US FDA)
- FDA product code: ETD

## Overview

*AI-generated summary, 2026-09-25. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

This device is a tube, tympanostomy, as defined in the device name and openFDA data. It is classified as a Class II medical device under regulation number 874.3880 and is intended for use in the ear, nose, and throat medical specialty.

The device received traditional 510(k) clearance (K812460) from the FDA on September 21, 1981, and is substantially equivalent to a legally marketed predicate device. It is manufactured by Exmoor Plastics, Ltd., and is identified by the product code ETD. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or clinical indications is provided in the data.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K812460 · decision 1981-09-21 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K812460 [FDA 510(k)]
- FDA product code: ETD [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 874.3880 [FDA 510(k)]
- Advisory committee: Ear, Nose, Throat [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Various Aural Grommets, Exmoor Plastics Limited. deviCERTS medical device catalogue. https://devicerts.com/devices/various-aural-grommets-etd (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-11-13
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/various-aural-grommets-etd.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/various-aural-grommets-etd
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.