Fujifilm Ep-8000
Fujifilm Ep-8000 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K261880 on 2 Jul 2026 (2 earlier submissions) and listed in FDA GUDID since 31 May 2025 (UDI-DI 04547410513790), 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 | NumberK261880 | Date2 Jul 2026 | StatusActive |
| United States | GUDID listing | Number04547410513790 | Date31 May 2025 | StatusListed |
Official records
- AccessGUDID record 04547410513790
- FDA 510(k) database K261880
- FDA 510(k) database K244017
- FDA 510(k) database K243260
Across registries
- FDA 510(k) K261880 decided 2 Jul 2026 Active
- FDA GUDID UDI-DI 04547410513790 listed 31 May 2025 Listed
Timeline
- Cleared FDA 510(k) K243260
- Listed FDA GUDID 04547410513790
- Cleared FDA 510(k) K244017
- Cleared FDA 510(k) K261880
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fujifilm
- Generic name
- Endoscopic video image processing/light source system
- Model / reference
- EP-8000
- Primary DI / UDI-DI
- 04547410513790
- FDA product code
- FET, NTN, NWB, PEA, FDS, EOQ
- GMDN term
- Endoscopic video image processing/light source system
- Device class
- Class II
- Regulation number
- 876.1500, 874.4680
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Hydrogen Peroxide
Similar devices in this category
Other devices filed under Endoscopic video image processing/light source system.