Fujifilm Tr-1208A
Fujifilm Tr-1208A is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K230752 on 15 Sep 2023 and listed in FDA GUDID since 23 Oct 2023 (UDI-DI 04547410484687), 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 | Number04547410484687 | Date23 Oct 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230752 | Date15 Sep 2023 | StatusActive |
Official records
- AccessGUDID record 04547410484687
- FDA 510(k) database K230752
Across registries
- FDA 510(k) K230752 decided 15 Sep 2023 Active
- FDA GUDID UDI-DI 04547410484687 listed 23 Oct 2023 Listed
Timeline
- Cleared FDA 510(k) K230752
- Listed FDA GUDID 04547410484687
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fujifilm
- Generic name
- Endoscopic overtube, single-use
- Model / reference
- TR-1208A
- Primary DI / UDI-DI
- 04547410484687
- 510(k) Number
- FDA product code
- FED
- GMDN term
- Endoscopic overtube, single-use
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Endoscopic overtube, single-use.