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Solo+ Tympanostomy Tube Device (TTD)

by Aventamed Dac Ireland 510(k)

510(k) K232702 Product code ETD

Overview

The Solo+ Tympanostomy Tube Device (TTD) is a medical device used for tympanostomy tube placement. It is designed to provide a new procedure for ENT surgeons to implant grommets (ear tubes) using topical anesthesia. The device is classified as a Tube, Tympanostomy, and is used in the Ear, Nose, Throat medical specialty.

The Solo+ Tympanostomy Tube Device (TTD) is supplied with regulatory authorizations, including FDA 510K clearance. The device is available in various sizes and is intended for use in a clinical setting. It is stored and handled according to standard medical device protocols, and its use is subject to the regulations and guidelines set forth by the relevant authorities, including those related to device class and registration number.

Summary written by AI from registry data, 23 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232702 Date20 May 2024ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k) · synced 6 Oct 2026

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

Other devices from Aventamed Dac

Questions

  • What is the Solo+ Tympanostomy Tube Device used for?

    The Solo+ Tympanostomy Tube Device is used for tympanostomy tube placement, providing a new procedure for ENT surgeons to implant grommets (ear tubes) using topical anesthesia.

  • Is the Solo+ Tympanostomy Tube Device available in different sizes?

    Yes, the Solo+ Tympanostomy Tube Device is available in various sizes to accommodate different patient needs.

  • How is the Solo+ Tympanostomy Tube Device stored and handled?

    The device is stored and handled according to standard medical device protocols, following relevant regulations and guidelines.

  • What regulatory authorizations does the Solo+ Tympanostomy Tube Device have?

    The Solo+ Tympanostomy Tube Device has FDA 510K clearance, indicating it has been found to be substantially equivalent to a predicate device.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K232702 24 fields · synced 6 Oct 2026