FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
FDA 510(k) clearance K042076 · decided 2004-11-18
Clearance details
- K-number
- K042076
- Device name
- FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
- Applicant
- Fujinon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-02
- Decision date
- 2004-11-18
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- FDT
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Huntington, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED- recall (Z-2778-2015) | Fujifilm Medical Systems U.S.A., Inc. | 2015-09-17 |