Acu-Evac Txpack
Acu-Evac Txpack is a Class II device made by Acuderm, Inc., cleared under FDA 510(k) K930043 on 9 Feb 1994 and listed in FDA GUDID since 3 Jan 2020 (UDI-DI 10814105020491), active 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 | Number10814105020491 | Date3 Jan 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK930043 | Date9 Feb 1994 | StatusActive |
Official records
- AccessGUDID record 10814105020491
- FDA 510(k) database K930043
Across registries
- FDA 510(k) K930043 decided 9 Feb 1994 Active
- FDA GUDID UDI-DI 10814105020491 listed 3 Jan 2020 Listed
Timeline
- Cleared FDA 510(k) K930043
- Listed FDA GUDID 10814105020491
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acu-Evac
- Generic name
- Surgical plume evacuation system
- Model / reference
- TXPACK
- Primary DI / UDI-DI
- 10814105020491
- 510(k) Number
- FDA product code
- FYD
- GMDN term
- Surgical plume evacuation system
- Device class
- Class II
- Regulation number
- 878.5070
- GUDID distribution status
- In Commercial Distribution
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