Tympanostomy (Ventilation) Tube
FDA 510(k) K941407 · Xomed-Treace, Inc.
510(k) numberK941407
Submission
- Device name
- Tympanostomy (Ventilation) Tube
- Applicant
- Xomed-Treace, Inc.
Jacksonville, FL, US - Received
- March 23, 1994
- Decision date
- March 14, 1995
- 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 |
|---|---|---|
| K940028 | Endoscope SheathEOB · Traditional | 03/24/1995SE |
| K945659 | Blackstar(Tm) Star SystemERL · Traditional | 01/09/1995SE |
| K932771 | Battery Powered, Disposable Endoscope Light SourceEQH · Traditional | 08/24/1994SE |
| K933672 | Xomed-Treace ScopesheathEOB · Traditional | 07/18/1994SE |
| K934426 | Nerve Integrity MONITOR-2 (NIM-2 XL)ETN · Traditional | 05/13/1994SE |
| K933105 | Xomed-Treace Rigid Rod Lens EndoscopeEOB · Traditional | 01/05/1994SE |
| K925640 | Xomed-Treace Emg Endotracheal TubeenETN · Traditional | 08/17/1993SE |
| K922880 | Xomed Treace Jet Ventilation TubeBTR · Traditional | 04/15/1993SE |
| K923830 | Xomed-Treace AlphascopeERA · Traditional | 11/09/1992SE |
| K912753 | Xomed-Treace Positrol Footpedal Suction ControlGCX · Traditional | 09/23/1991SE |
Questions and answers
When was Tympanostomy (Ventilation) Tube cleared by the FDA?
Tympanostomy (Ventilation) Tube (K941407) received a 510(k) decision of Substantially Equivalent on March 14, 1995, 356 days after the submission was received.
What is the product code of K941407?
The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.