Fujifilm Eb-530S
Fujifilm Eb-530S is a flexible video bronchoscope (FDA Class II; FDA product code EOQ, Bronchoscope (Flexible or Rigid)) made by Fujifilm Corporation, cleared under FDA 510(k) K122535 on 13 Dec 2012 and listed in FDA GUDID since 14 Dec 2016 (UDI-DI 04547410333312), 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 | GUDID listing | Number04547410333312 | Date14 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122535 | Date13 Dec 2012 | StatusActive |
Official records
- AccessGUDID record 04547410333312
- FDA 510(k) database K122535
Across registries
- FDA 510(k) K122535 decided 13 Dec 2012 Active
- FDA GUDID UDI-DI 04547410333312 listed 14 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K122535
- Listed FDA GUDID 04547410333312
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fujifilm
- Generic name
- Flexible video bronchoscope, reusable
- Model / reference
- EB-530S
- Primary DI / UDI-DI
- 04547410333312
- 510(k) Number
- FDA product code
- EOQ
- GMDN term
- Flexible video bronchoscope, reusable
- Device class
- Class II
- Regulation number
- 874.4680
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Flexible video bronchoscope, reusable.