ETD · Tube, Tympanostomy
Ear, Nose, Throat · 21 CFR 874.3880 · Class 2
Overview
| Product Code | ETD |
|---|---|
| Device Name | Tube, Tympanostomy |
| Regulation | 21 CFR 874.3880 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
Identification
A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 115)
Showing 20 most recent of 115 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) | Aventamed Dac | Apr 28, 2025 | SESE |
| K232702 | Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac | May 20, 2024 | SESE |
| K233658 | Biowy Tym Tube (TT) | Biowy Corporation | Feb 16, 2024 | SESE |
| K232059 | Tympanostomy Tubes | Grace Medical, Inc. | Nov 24, 2023 | SESE |
| K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | Jul 27, 2022 | SESE |
| K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | Jun 5, 2020 | SESE |
| K171239 | TULA Tube Delivery System | Tusker Medical | Jun 28, 2017 | SESE |
| K151830 | Hummingbird Tympanostomy Tube | Preceptis Medical | Sep 21, 2015 | SESE |
| K151067 | Ventilation (Tympanostomy) Tubes | Medtronic Xomed, Inc. | Jul 22, 2015 | SESE |
| K142282 | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) | Preceptis Medical | Apr 23, 2015 | SESE |
| K133921 | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | Preceptis Medical | Aug 22, 2014 | SESE |
| K103595 | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM | Acclarent, Inc. | Apr 1, 2011 | SESE |
| K082188 | TYMPANOSTOMY TUBE | Acclarent, Inc. | Sep 19, 2008 | SESE |
| K071150 | TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE | Heinz Kurz GmbH Medizintechnik | Dec 12, 2007 | SESE |
| K071178 | OTOMEDICS SOFT TYMPANOSTOMY TUBE | Otomedics Advanced Medical Technologies, Ltd. | Jun 22, 2007 | SESE |
| K062672 | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES | Grace Medical, Inc. | Oct 24, 2006 | SESE |
| K062385 | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES | Grace Medical, Inc. | Sep 27, 2006 | SESE |
| K061058 | NEOZOLINE VENTILATION TUBES | Adept Medical, Ltd. | Jul 12, 2006 | SESE |
| K011383 | MICRODOSE CATH, MODELS 90121-201, -202, -203 | Durect Corp. | Jun 25, 2001 | SESE |
| K000801 | PC COATED FLUOROPLASTIC VENT TUBES | Gyrus Ent LLC | Jun 19, 2000 | SESE |
Top Applicants
- Exmoor Plastics , Ltd. — 16 clearances
- Xomed, Inc. — 13 clearances
- Treace Medical, Inc. — 9 clearances
- Micromed Development Corp. — 5 clearances
- Grace Medical, Inc. — 5 clearances
