XTJF TYPE Q160VF1
FDA 510(k) clearance K080403 · decided 2008-05-20
Clearance details
- K-number
- K080403
- Device name
- XTJF TYPE Q160VF1
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-02-14
- Decision date
- 2008-05-20
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- FDT
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument ha recall (Z-0757-2016) | Olympus Corporation of the Americas | 2016-02-04 |
| EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed t recall (Z-2807-2015) | Olympus America Inc. | 2015-09-22 |