Tympanostomy Tube
FDA 510(k) K943325 · Grace Medical, Inc.
510(k) numberK943325
Submission
- Device name
- Tympanostomy Tube
- Applicant
- Grace Medical, Inc.
Memphis, TN, US - Received
- July 11, 1994
- Decision date
- October 11, 1994
- 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 |
| 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 |
More from Medtronic Xomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260266 | Tympendi (810)KHJ · Traditional | 08/18/2026SE |
| K232059 | Tympanostomy TubesETD · Traditional | 11/24/2023SE |
| K161376 | DragonFly Surgical Drill SystemERL · Traditional | 08/25/2016SE |
| K091187 | Grace Dynamic TorpETA · Traditional | 09/14/2009SE |
| K080070 | K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesETB · Traditional | 04/17/2008SE |
| K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…ETB · Traditional | 12/06/2006SE |
| K062672 | Grace Medical PC Coated Tympanostomy TubesETD · Traditional | 10/24/2006SE |
| K062385 | Blue PTFE (Fluoroplastic) Ventilation TubesETD · Traditional | 09/27/2006SE |
| K061853 | Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesETB · Traditional | 08/18/2006SE |
| K060518 | Partial Ossicular Replacement ProsthesesETB · Traditional | 06/28/2006SE |
Questions and answers
When was Tympanostomy Tube cleared by the FDA?
Tympanostomy Tube (K943325) received a 510(k) decision of Substantially Equivalent on October 11, 1994, 92 days after the submission was received.
What is the product code of K943325?
The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.