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Tytan Grommet Vent Tube, .040

by Treace Medical, Inc.

510(k) K822366

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 NumberK822366 Date2 Sep 1982ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The Tytan Grommet Vent Tube, .040 is a tympanostomy tube, as defined by its device name and classification under product code ETD. It is a small ventilating tube designed for insertion into the tympanic membrane to facilitate middle ear aeration and fluid drainage.

It is supplied as a single-use device and has received FDA 510(k) clearance (K822366) under regulation number 874.3880, with a traditional clearance pathway and Ear, Nose, Throat advisory committee review. The device is intended for use in clinical settings for tympanostomy procedures, and its specifications include the exact model designation .040 as part of its identity.

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