Fujifilm Gw-100
Fujifilm Gw-100 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K180711 on 25 May 2018 (1 earlier submission) and listed in FDA GUDID since 14 Dec 2016 (UDI-DI 04547410331592), 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 | NumberK180711 | Date25 May 2018 | StatusActive |
| United States | GUDID listing | Number04547410331592 | Date14 Dec 2016 | StatusListed |
Official records
- AccessGUDID record 04547410331592
- FDA 510(k) database K180711
- FDA 510(k) database K133976
Across registries
- FDA 510(k) K180711 decided 25 May 2018 Active
- FDA GUDID UDI-DI 04547410331592 listed 14 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K133976
- Listed FDA GUDID 04547410331592
- Cleared FDA 510(k) K180711
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fujifilm
- Generic name
- Gastrointestinal endoscopic insufflator
- Model / reference
- GW-100
- Primary DI / UDI-DI
- 04547410331592
- FDA product code
- FCX
- GMDN term
- Gastrointestinal endoscopic insufflator
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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