ProGen PRP Eclipse P5PG052
ProGen PRP Eclipse P5PG052 (PROGEN-A15) is a Class II device made by Bellus Medical, LLC, listed under FDA premarket submission BK170136 and listed in FDA GUDID since 28 Aug 2024 (UDI-DI 00850060751110), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK170136
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850060751110 | Date28 Aug 2024 | StatusListed |
| United States | FDA 510(k) | NumberBK170136 | Date— | StatusActive |
Official records
- AccessGUDID record 00850060751110
Across registries
- FDA premarket submission BK170136 Active
- FDA GUDID UDI-DI 00850060751110 listed 28 Aug 2024 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ProGen PRP Eclipse
- Generic name
- Autologous platelet-based product centrifuge tube
- Model / Ref / Catalog
- P5PG052, PROGEN-A15
- Primary DI / UDI-DI
- 00850060751110
- FDA product code
- ORG
- GMDN term
- Autologous platelet-based product centrifuge tube
- Device class
- Class II
- Regulation number
- 864.9245
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ORG (Platelet And Plasma Separator For Bone Graft Handling).