Exmoor Aural Grommet AG/T2L
FDA 510(k) K810702 · Exmoor Plastics , Ltd.
510(k) numberK810702
Submission
- Device name
- Exmoor Aural Grommet AG/T2L
- Applicant
- Exmoor Plastics , Ltd.
Walker, MI, US - Received
- March 16, 1981
- Decision date
- April 14, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K093863 | EpidrumFMF · Traditional | 05/10/2010SE |
| K990366 | Exmoor Suction Clearance KitLRC · Traditional | 03/05/1999SE |
| K980828 | Exmoor Myringotomy KitETD · Traditional | 10/22/1998SE |
| K981143 | Dilkes Laser/Suction CannulaeGEX · Traditional | 09/14/1998SE |
| K972700 | Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell MD Facs Pattern)KHJ · Traditional | 07/16/1998SE |
| K981088 | Mills Columella ProsthesisETA · Traditional | 06/05/1998SE |
| K981045 | Exmoor Teflon Loop Replacement ProsthesisETB · Traditional | 05/20/1998SE |
| K974008 | Pfleiderer's Intratympanic CatheterETD · Traditional | 05/13/1998SE |
| K974224 | Endolymphatic Sac to Mastoid T-ShuntESZ · Traditional | 01/27/1998SE |
| K973587 | Exmoor Tympanocentesis Kit (TK/1)JZF · Traditional | 01/23/1998SE |
Questions and answers
When was Exmoor Aural Grommet AG/T2L cleared by the FDA?
Exmoor Aural Grommet AG/T2L (K810702) received a 510(k) decision of Substantially Equivalent on April 14, 1981, 29 days after the submission was received.
What is the product code of K810702?
The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.