Gromment Style Venturi Tube
FDA 510(k) K943849 · Micromed Development Corp.
510(k) numberK943849
Submission
- Device name
- Gromment Style Venturi Tube
- Applicant
- Micromed Development Corp.
Clearwater, FL, US - Received
- August 4, 1994
- Decision date
- September 2, 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
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| 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 |
|---|---|---|
| K945105 | Poly/Platinum Wire PistonETB · Traditional | 05/14/1996SE |
| K945831 | Disposable Joint Aspiration/Injection Diagnostic KitLRO · Traditional | 01/20/1995SE |
| K945242 | Nerve Monitor Electrodes/Stimulator ProbesETN · Traditional | 12/27/1994SE |
| K945438 | Edi-Bur Microdrill SystemsERL · Traditional | 11/22/1994SE |
| K945108 | Poly PistonETB · Traditional | 11/22/1994SE |
| K945107 | Poly-Wire PistonETB · Traditional | 11/22/1994SE |
| K945106 | Micromed Total Regular and Partial OffsetETA · Traditional | 11/22/1994SE |
| K945104 | Micromed Partial Regular and Partial OffsetETB · Traditional | 11/22/1994SE |
| K943848 | Collar Button Venturi Vent TubeETD · Traditional | 09/16/1994SE |
| K943847 | Bobbin Style Venturi Vent TubeETD · Traditional | 09/02/1994SE |
Questions and answers
When was Gromment Style Venturi Tube cleared by the FDA?
Gromment Style Venturi Tube (K943849) received a 510(k) decision of Substantially Equivalent on September 2, 1994, 29 days after the submission was received.
What is the product code of K943849?
The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.