Solo+ Tympanostomy Tube Device (TTD)
FDA 510(k) K232702 · Aventamed Dac
510(k) numberK232702
Submission
- Device name
- Solo+ Tympanostomy Tube Device (TTD)
- Applicant
- Aventamed Dac
Bishopstown, IE - Received
- September 5, 2023
- Decision date
- May 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ETD – Tube, Tympanostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3880
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code ETD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252436 | Tula Tympanostomy Tube Delivery DeviceETD · Traditional | Tusker Medical, Inc. | 04/23/2026SE |
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube…ETD · Traditional | Aventamed Dac | 04/28/2025SE |
| K233658 | Biowy Tym Tube (TT)ETD · Traditional | Biowy Corporation | 02/16/2024SE |
| K232059 | Tympanostomy TubesETD · Traditional | Grace Medical, Inc. | 11/24/2023SE |
| K221254 | Hummingbird Tympanostomy Tube SystemETD · Traditional | Preceptis Medical, Inc. | 07/27/2022SE |
| K200952 | Hummingbird Tympanostomy Tube SystemETD · Traditional | Preceptis Medical, Inc. | 06/05/2020SE |
| K171239 | TULA Tube Delivery SystemETD · Special | Tusker Medical | 06/28/2017SE |
| K151830 | Hummingbird Tympanostomy TubeETD · Traditional | Preceptis Medical | 09/21/2015SE |
| K151067 | Ventilation (Tympanostomy) TubesETD · Traditional | Medtronic Xomed, Inc. | 07/22/2015SE |
| K142282 | Hummingbird(Tm) Tympanostomy Tube System (TTS)ETD · Traditional | Preceptis Medical | 04/23/2015SE |
More from Preceptis Medical
| 510(k) | Device | Decision |
|---|---|---|
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube…ETD · Traditional | 04/28/2025SE |
Questions and answers
When was Solo+ Tympanostomy Tube Device (TTD) cleared by the FDA?
Solo+ Tympanostomy Tube Device (TTD) (K232702) received a 510(k) decision of Substantially Equivalent on May 20, 2024, 258 days after the submission was received.
What is the product code of K232702?
The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.