Vt-0509-01
Vt-0509-01 is a tympanostomy tube (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Summit Medical, LLC, cleared under FDA 510(k) K830228 on 7 Mar 1983 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00385640001366), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00385640001366 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK830228 | Date7 Mar 1983 | StatusActive |
Official records
- AccessGUDID record 00385640001366
- FDA 510(k) database K830228
Across registries
- FDA 510(k) K830228 decided 7 Mar 1983 Active
- FDA GUDID UDI-DI 00385640001366 listed 12 Sep 2016 Listed
Recalls
-
- Terminated Z-1731-2014
One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.
Timeline
- Cleared FDA 510(k) K830228
- Recall initiated FDA recalls Z-1731-2014
- Listed FDA GUDID 00385640001366
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Tympanostomy tube
- Model / reference
- VT-0509-01
- Primary DI / UDI-DI
- 00385640001366
- 510(k) Number
- FDA product code
- ETD
- GMDN term
- Tympanostomy tube
- Device class
- Class II
- Regulation number
- 874.3880
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Tympanostomy tube.