Ventilation Tubes
510(k) K960477
Ventilation Tubes is a medical device (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Smith & Nephew, Inc., cleared under FDA 510(k) K960477 on 26 Feb 1996, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK960477 | Date26 Feb 1996 | StatusActive |
Official records
- FDA 510(k) database K960477
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ETD
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3880
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K960477
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| GYRUS ACMI 70240280 | 70240280 | 00821925032217 | — | On the market |
| GYRUS ACMI 70240281 | 70240281 | 00821925032699 | — | On the market |
| Gyrus ACMI 70240282 | 70240282 | 00821925032750 | — | On the market |
| GYRUS ACMI 70241000 | 70241000 | 00821925032071 | — | On the market |
| Gyrus ACMI 70241001 | 70241001 | 00821925032651 | — | On the market |
| GYRUS ACMI 70241014 | 70241014 | 00821925031876 | — | On the market |
| GYRUS ACMI 70241015 | 70241015 | 00821925034440 | — | On the market |
| GYRUS ACMI 70241020 | 70241020 | 00821925032576 | — | On the market |
| GYRUS ACMI 70241036 | 70241036 | 00821925032187 | — | On the market |
| GYRUS ACMI 70241044 | 70241044 | 00821925032163 | — | On the market |
| GYRUS ACMI 70241046 | 70241046 | 00821925032583 | — | No longer on the market |
| GYRUS ACMI 70241050 | 70241050 | 00821925032026 | — | On the market |
| GYRUS ACMI 70241052 | 70241052 | 00821925032712 | — | No longer on the market |
| GYRUS ACMI 70241071 | 70241071 | 00821925032224 | — | On the market |
| GYRUS ACMI 70241072 | 70241072 | 00821925031920 | — | On the market |
| GYRUS ACMI 70241073 | 70241073 | 00821925032590 | — | On the market |
| Gyrus ACMI 70241075 | 70241075 | 00821925031968 | — | On the market |
| GYRUS ACMI 70241076 | 70241076 | 00821925037854 | — | On the market |
| GYRUS ACMI 70241314 | 70241314 | 00821925032040 | — | On the market |
| GYRUS ACMI 70241344 | 70241344 | 00821925032521 | — | On the market |
| GYRUS ACMI 70241350 | 70241350 | 00821925032484 | — | On the market |
| GYRUS ACMI 70241375 | 70241375 | 00821925032330 | — | On the market |
| Gyrus ACMI 70241380 | 70241380 | 00821925039711 | — | On the market |
| Gyrus ACMI 70245755 | 70245755 | 00821925032767 | — | On the market |
| Gyrus ACMI 70921773 | 70921773 | 00821925032934 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code ETD (Tube, Tympanostomy).
- Gyrus ACMI 240074 by Gyrus Acmi, Inc.
- GYRUS ACMI 70245012 by Gyrus Acmi, Inc.
- TYMPANOSTOMY TUBE by Grace Medical, Inc.
- EXMOOR AURAL GROMMET AG/T5 by Exmoor Plastics Limited
- EXMOOR AURAL GROMMET AG/T2 by Exmoor Plastics Limited
- MYRINGOTOMY TUBE by Mednet Locator, Inc.
- TSH RIA by Syncor Intl. Corp.
- POPE UMBRELLA TUBE by Xomed, Inc.
- MICRODOSE CATH, MODELS 90121-201, -202, -203 by Durect Corp.
- UNIFLOW VENT TUBE by Richards Medical Co., Inc.