Fujifilm Dh-17EN
Fujifilm Dh-17EN is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K143556 on 20 Aug 2015 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04547410074093), 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 | Number04547410074093 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143556 | Date20 Aug 2015 | StatusActive |
Official records
- AccessGUDID record 04547410074093
- FDA 510(k) database K143556
Across registries
- FDA 510(k) K143556 decided 20 Aug 2015 Active
- FDA GUDID UDI-DI 04547410074093 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K143556
- Listed FDA GUDID 04547410074093
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fujifilm
- Generic name
- Endoscope tissue removal cap, single-use
- Model / reference
- DH-17EN
- Primary DI / UDI-DI
- 04547410074093
- 510(k) Number
- FDA product code
- FDF, FDA
- GMDN term
- Endoscope tissue removal cap, single-use
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution