Tula Tympanostomy Tube Delivery Device
FDA 510(k) K252436 · Tusker Medical, Inc.
510(k) numberK252436
Submission
- Device name
- Tula Tympanostomy Tube Delivery Device
- Applicant
- Tusker Medical, Inc.
Austin, TX, US - Received
- August 1, 2025
- Decision date
- April 23, 2026
- 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 |
|---|---|---|---|
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube…ETD · Traditional | Aventamed Dac | 04/28/2025SE |
| K232702 | Solo+ Tympanostomy Tube Device (TTD)ETD · Traditional | Aventamed Dac | 05/20/2024SE |
| 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 |
|---|---|---|
| K171239 | TULA Tube Delivery SystemETD · Special | 06/28/2017SE |
Questions and answers
When was Tula Tympanostomy Tube Delivery Device cleared by the FDA?
Tula Tympanostomy Tube Delivery Device (K252436) received a 510(k) decision of Substantially Equivalent on April 23, 2026, 265 days after the submission was received.
What is the product code of K252436?
The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.