ETD — Tube, Tympanostomy Class II
FDA product code ETD covers "Tube, Tympanostomy", a Class II medical device regulated under 21 CFR 874.3880. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ETD
- Device Class
- Class II
- Regulation Number
- 874.3880
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252436 | tusker medical | Tula Tympanostomy Tube Delivery Device | April 23, 2026 |
| K250256 | aventamed dac | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube | April 28, 2025 |
| K232702 | aventamed dac | Solo+ Tympanostomy Tube Device (TTD) | May 20, 2024 |
| K233658 | biowy corporation | Biowy Tym Tube (TT) | February 16, 2024 |
| K232059 | grace medical | Tympanostomy Tubes | November 24, 2023 |
| K221254 | preceptis medical | Hummingbird Tympanostomy Tube System | July 27, 2022 |
| K200952 | preceptis medical | Hummingbird Tympanostomy Tube System | June 5, 2020 |
| K171239 | tusker medical | TULA Tube Delivery System | June 28, 2017 |
| K151830 | preceptis medical | Hummingbird Tympanostomy Tube | September 21, 2015 |
| K151067 | medtronic xomed | Ventilation (Tympanostomy) Tubes | July 22, 2015 |
| K142282 | preceptis medical | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) | April 23, 2015 |
| K133921 | preceptis medical | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | August 22, 2014 |
| K103595 | acclarent | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM | April 1, 2011 |
| K082188 | acclarent | TYMPANOSTOMY TUBE | September 19, 2008 |
| K071150 | heinz kurz gmbh medizintechnik | TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076 | December 12, 2007 |
| K071178 | otomedics advanced medical technologies | OTOMEDICS SOFT TYMPANOSTOMY TUBE | June 22, 2007 |
| K062672 | grace medical | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES | October 24, 2006 |
| K062385 | grace medical | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES | September 27, 2006 |
| K061058 | adept medical | NEOZOLINE VENTILATION TUBES | July 12, 2006 |
| K011383 | durect | MICRODOSE CATH, MODELS 90121-201, -202, -203 | June 25, 2001 |