Fujifilm Ec-530HL2
Fujifilm Ec-530HL2 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K112391 on 26 Jul 2012 and listed in FDA GUDID since 14 Dec 2016 (UDI-DI 04547410323856), 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 | Number04547410323856 | Date14 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112391 | Date26 Jul 2012 | StatusActive |
Official records
- AccessGUDID record 04547410323856
- FDA 510(k) database K112391
Across registries
- FDA 510(k) K112391 decided 26 Jul 2012 Active
- FDA GUDID UDI-DI 04547410323856 listed 14 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K112391
- Listed FDA GUDID 04547410323856
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fujifilm
- Generic name
- Flexible video colonoscope, reusable
- Model / reference
- EC-530HL2
- Primary DI / UDI-DI
- 04547410323856
- 510(k) Number
- FDA product code
- FDF
- GMDN term
- Flexible video colonoscope, reusable
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FDF (Colonoscope and accessories, flexible/rigid).
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- White cap MH-155 by Olympus Medical Systems Corporation
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- FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 by Fujinon, Inc.
- CLEARPATH by Easyglide, Ltd.