Celerity PCC0075
Celerity PCC0075 (PCC075) is a Class II device made by Albert Browne, Ltd., cleared under FDA 510(k) K231488 on 7 Aug 2023 (1 earlier submission) and listed in FDA GUDID since 1 Nov 2019 (UDI-DI 10724995164741), 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 | NumberK231488 | Date7 Aug 2023 | StatusActive |
| United States | GUDID listing | Number10724995164741 | Date1 Nov 2019 | StatusListed |
Official records
- AccessGUDID record 10724995164741
- FDA 510(k) database K231488
- FDA 510(k) database K192020
Across registries
- FDA 510(k) K231488 decided 7 Aug 2023 Active
- FDA GUDID UDI-DI 10724995164741 listed 1 Nov 2019 Listed
Timeline
- Cleared FDA 510(k) K192020
- Listed FDA GUDID 10724995164741
- Cleared FDA 510(k) K231488
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Celerity
- Generic name
- Chemical/physical sterilization process indicator
- Model / Ref / Catalog
- PCC0075, PCC075
- Primary DI / UDI-DI
- 10724995164741
- FDA product code
- JOJ
- GMDN term
- Chemical/physical sterilization process indicator
- Device class
- Class II
- Regulation number
- 880.2800
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Chemical/physical sterilization process indicator.