Identifiers
- 510(k) Number
- K810701 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)
The Exmoor Aural Grommet is a tympanostomy tube designed to ventilate the middle ear cleft. It functions as a medical device intended to facilitate pressure equalization and drainage within the ear.
This device is regulated under FDA 510(k) clearance K810701. It is classified as a class 2 medical device under regulation number 874.3880.
Frequently asked questions
What is the primary function of the Exmoor Aural Grommet?
The Exmoor Aural Grommet is a tympanostomy tube specifically designed to ventilate the middle ear cleft. Its function is to facilitate effective pressure equalization and drainage within the ear.
How is this device classified for regulatory purposes?
The Exmoor Aural Grommet is classified as a class 2 medical device under regulation number 874.3880. It has received FDA 510(k) clearance under the number K810701.
Which medical specialty uses this device?
This device is categorized under the Ear, Nose, and Throat (ENT) medical specialty, as it is designed for procedures involving the middle ear cleft.
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: EXMOOR AURAL GROMMET (K810701) — FDA 510 (k) | Innolitics, EXMOOR AURAL GROMMET AG/T5 (K810706) — FDA 510(k) | Innolitics, Exmoor Aural Grommets 00ZGROMMET - C.R.Kennedy, EXMOOR AURAL GROMMET 510 (k) K810701 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K810701 | Class II | Active |
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Manufacturer
- Manufacturer
- Exmoor Plastics , Ltd.
Sources (1)
- FDA 510(k) K810701 24 fields · synced Sep 24, 2026