Product code ETD
- Device name
- Tube, Tympanostomy
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.3880
- Review panel
- EN
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | 2026-04-23 |
| 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 | 2025-04-28 |
| K232702 | Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac | 2024-05-20 |
| K233658 | Biowy Tym Tube (TT) | Biowy Corporation | 2024-02-16 |
| K232059 | Tympanostomy Tubes | Grace Medical, Inc. | 2023-11-24 |
| K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2022-07-27 |
| K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2020-06-05 |
| K171239 | TULA Tube Delivery System | Tusker Medical | 2017-06-28 |
| K151830 | Hummingbird Tympanostomy Tube | Preceptis Medical | 2015-09-21 |
| K151067 | Ventilation (Tympanostomy) Tubes | Medtronic Xomed, Inc. | 2015-07-22 |
| K142282 | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) | Preceptis Medical | 2015-04-23 |
| K133921 | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | Preceptis Medical | 2014-08-22 |
| K103595 | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM | Acclarent, Inc. | 2011-04-01 |
| K082188 | TYMPANOSTOMY TUBE | Acclarent, Inc. | 2008-09-19 |
| 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 | 2007-12-12 |
| K071178 | OTOMEDICS SOFT TYMPANOSTOMY TUBE | Otomedics Advanced Medical Technologies, Ltd. | 2007-06-22 |
| K062672 | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES | Grace Medical, Inc. | 2006-10-24 |
| K062385 | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES | Grace Medical, Inc. | 2006-09-27 |
| K061058 | NEOZOLINE VENTILATION TUBES | Adept Medical, Ltd. | 2006-07-12 |
| K011383 | MICRODOSE CATH, MODELS 90121-201, -202, -203 | Durect Corp. | 2001-06-25 |
| K000801 | PC COATED FLUOROPLASTIC VENT TUBES | Gyrus Ent LLC | 2000-06-19 |
| K992222 | FLUOROPLASTIC VENTILATION TUBES | Gyrus Ent LLC | 1999-08-26 |
| K991670 | SILVERSTEIN MICROWICK | Micromedics, Inc. | 1999-08-26 |
| K980828 | EXMOOR MYRINGOTOMY KIT | Exmoor Plastics , Ltd. | 1998-10-22 |
| K981575 | TYMPANOSTOMY TUBE | Grace Medical, Inc. | 1998-07-15 |
| K974008 | PFLEIDERER'S INTRATYMPANIC CATHETER | Exmoor Plastics , Ltd. | 1998-05-13 |
| K973740 | ROUND WINDOW E-CATH | Neuro-Biometrix, Inc. | 1998-03-23 |
| K974007 | SHAH PERMAVENT | Exmoor Plastics , Ltd. | 1997-12-12 |
| K973226 | TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) | Heinz Kurz GmbH Medizintechnik | 1997-11-04 |
| K972126 | MYRINGOTOMY TUBE | Mednet Locator, Inc. | 1997-07-29 |
Related GUDID Devices#
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| 09421901970864 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970857 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970840 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970833 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970826 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970413 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970406 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970390 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970383 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970376 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970369 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970352 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970345 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970338 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970314 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-25 |
| 09421901970178 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970307 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970291 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970284 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970277 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970260 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970253 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970246 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970239 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970222 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970215 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970208 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970192 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |
| 09421901970185 | NeoZoline | ADEPT MEDICAL LIMITED | 2016-02-24 |