Defina Epk-3000
by Hoya Corporation 2 variants
Defina Epk-3000 is a Class II device made by Hoya Corporation, cleared under FDA 510(k) K172156 on 5 Apr 2018 and listed in FDA GUDID since 31 Oct 2023 (UDI-DI 04961333249183), active as of 22 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 | Number04961333249183 | Date31 Oct 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172156 | Date5 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 04961333249183
- FDA 510(k) database K172156
Across registries
- FDA 510(k) K172156 decided 5 Apr 2018 Active
- FDA GUDID UDI-DI 04961333249183 listed 31 Oct 2023 Listed
Timeline
- Cleared FDA 510(k) K172156
- Listed FDA GUDID 04961333249183
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Defina
- Generic name
- Endoscopic video image processing unit
- Model / reference
- EPK-3000
- Primary DI / UDI-DI
- 04961333249183
- FDA product code
- PEA
- GMDN term
- Endoscopic video image processing unit
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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