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Various Aural Grommets

by Exmoor Plastics Limited

510(k) K812460

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 13 Nov 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 13 Nov 2026.

Regulatory status

as of registry sync 13 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812460 Date21 Sep 1981ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ETD
FDA applicant
Exmoor Plastics , Ltd.
Device class
Class II
Regulation
21 CFR Part 874.3880
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Similar devices

Other devices filed under FDA product code ETD (Tube, Tympanostomy).

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