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Collar Button Vent Tube

by Treace Medical, Inc. 2 variants

510(k) K823907

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK823907 Date28 Jan 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 874.3880
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The Collar Button Vent Tube is a tympanostomy tube used in ear, nose, and throat procedures. It is designed to provide ventilation to the middle ear by creating a temporary opening in the tympanic membrane.

The device is supplied as a single-use item and is regulated under FDA 510(k) clearance with product code ETD. It is available in various sizes and models, including K823907 and K830085, and is manufactured by Treace Medical, Inc.

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