Sterrad Velocity™ 43210
by Advanced Sterilization Products Services Inc.
Sterrad Velocity™ 43210 is a Class II device made by Advanced Sterilization Products Services Inc., cleared under FDA 510(k) K234084 on 5 Jul 2024 (2 earlier submissions) and listed in FDA GUDID since 10 Oct 2017 (UDI-DI 10705037048908), 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 | FDA 510(k)SESE | NumberK234084 | Date5 Jul 2024 | StatusActive |
| United States | GUDID listing | Number10705037048908 | Date10 Oct 2017 | StatusListed |
Official records
- AccessGUDID record 10705037048908
- FDA 510(k) database K234084
- FDA 510(k) database K192025
- FDA 510(k) database K170039
Across registries
- FDA 510(k) K234084 decided 5 Jul 2024 Active
- FDA GUDID UDI-DI 10705037048908 listed 10 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K170039
- Listed FDA GUDID 10705037048908
- Cleared FDA 510(k) K192025
- Cleared FDA 510(k) K234084
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sterrad Velocity™
- Generic name
- Biological sterilization indicator
- Model / Ref / Catalog
- 43210
- Primary DI / UDI-DI
- 10705037048908
- FDA product code
- FRC
- GMDN term
- Biological sterilization indicator
- Device class
- Class II
- Regulation number
- 880.2800
- GUDID distribution status
- In Commercial Distribution
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