Gyrus ACMI 70921773
Gyrus ACMI 70921773, a tympanostomy tube (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Gyrus Acmi, Inc., was cleared under FDA 510(k) K960477 on 26 Feb 1996 and listed in FDA GUDID on 6 Oct 2016 (UDI-DI 00821925032934); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00821925032934 | Date6 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK960477 | Date26 Feb 1996 | StatusActive |
Official records
- AccessGUDID record 00821925032934
- FDA 510(k) database K960477
Across registries
- FDA 510(k) K960477 decided 26 Feb 1996 Active
- FDA GUDID UDI-DI 00821925032934 listed 6 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K960477
- Listed FDA GUDID 00821925032934
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gyrus ACMI
- Generic name
- Tympanostomy tube
- Model / reference
- 70921773
- Primary DI / UDI-DI
- 00821925032934
- 510(k) Number
- FDA product code
- ETD
- GMDN term
- Tympanostomy tube
- Device class
- Class II
- Regulation number
- 874.3880
- GUDID distribution status
- Not in Commercial Distribution
Similar devices in this category
Other devices filed under Tympanostomy tube.