Evis Exera III Duodenovideoscope Olympus TJF-Q190V
FDA 510(k) clearance K193182 · decided 2020-01-17
Clearance details
- K-number
- K193182
- Device name
- Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2019-11-18
- Decision date
- 2020-01-17
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- FDT
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary recall (Z-0346-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V recall (Z-2467-2023) | Olympus Corporation of the Americas | 2023-08-28 |
| Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovide recall (Z-1613-2023) | Olympus Corporation of the Americas | 2023-05-19 |