SERIES 400 GASTROENTEROLOGY SYSTEM
FDA 510(k) clearance K944620 · decided 1995-04-27
Clearance details
- K-number
- K944620
- Device name
- SERIES 400 GASTROENTEROLOGY SYSTEM
- Applicant
- Marks & Murase
- Decision
- Substantially Equivalent
- Date received
- 1994-09-20
- Decision date
- 1995-04-27
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- FET
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- New York, NY, 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 |
| Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastro recall (Z-0708-06) | Fujinon Inc | 2006-04-05 |