Fujifilm Es-530WE
Fujifilm Es-530WE is a flexible video sigmoidoscope (FDA Class II; FDA product code FAM, sigmoidoscope and accessories, flexible/rigid) made by Fujifilm Corporation, cleared under FDA 510(k) K142629 on 14 May 2015 and listed in FDA GUDID since 14 Dec 2016 (UDI-DI 04547410333299), 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 | Number04547410333299 | Date14 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142629 | Date14 May 2015 | StatusActive |
Official records
- AccessGUDID record 04547410333299
- FDA 510(k) database K142629
Across registries
- FDA 510(k) K142629 decided 14 May 2015 Active
- FDA GUDID UDI-DI 04547410333299 listed 14 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K142629
- Listed FDA GUDID 04547410333299
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fujifilm
- Generic name
- Flexible video sigmoidoscope, reusable
- Model / reference
- ES-530WE
- Primary DI / UDI-DI
- 04547410333299
- 510(k) Number
- FDA product code
- FAM
- GMDN term
- Flexible video sigmoidoscope, reusable
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FAM (sigmoidoscope and accessories, flexible/rigid).
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- BRIDGE, SHORT DEFLECTING by V. Mueller O.V. Baxter Healthcare Corp.
- FS-34P2, FIBER SIGMOIDOSCOPE by Pentax Precision Instrument Corp.
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- SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 by Welch Allyn, Inc.
- SIGMOIDOSCOPE TIPLESS by Welch Allyn, Inc.
- FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE by Schott Fiber Optics, Inc.
- RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN by Icl Scientific