Identifiers
- 510(k) Number
- K812460 FDA 510(k)
- FDA Product Code
- ETD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3880 FDA 510(k)
- Regulation Number
- 874.3880 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What is VARIOUS AURAL GROMMETS used for?
VARIOUS AURAL GROMMETS is a tympanostomy tube intended for use in the ear, nose, and throat medical specialty, as indicated in the device name and openFDA data, to facilitate middle ear ventilation.
Is VARIOUS AURAL GROMMETS a single-use or reusable device?
The provided data does not specify whether VARIOUS AURAL GROMMETS is designed for single-use or reuse; no information on sterility, reusability, or reprocessing instructions is included in the device record.
What sizes or models are available for VARIOUS AURAL GROMMETS?
The device data does not list specific sizes, models, or reference numbers for VARIOUS AURAL GROMMETS; only the product name and product code ETD are provided without dimensional or variant details.
How is VARIOUS AURAL GROMMETS supplied and stored?
No details about packaging, storage conditions, temperature requirements, or shelf life are included in the device data for VARIOUS AURAL GROMMETS.
What regulatory pathway was used for VARIOUS AURAL GROMMETS?
VARIOUS AURAL GROMMETS received traditional 510(k) clearance (K812460) from the FDA on September 21, 1981, and was determined to be substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VARIOUS AURAL GROMMETS (K812460) — FDA 510 (k) | Innolitics, PDF K812460 - Various Aural Grommets, EXMOOR AURAL GROMMET (K810701) — FDA 510 (k) | Innolitics, Exmoor Plastics , Ltd. · DeviceClearance, FDA 510 (k), K812460, VARIOUS AURAL GROMMETS
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K812460 | Class II | Active |
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Manufacturer
- Manufacturer
- Exmoor Plastics , Ltd.
Sources (1)
- FDA 510(k) K812460 24 fields · synced Sep 25, 2026