Evis Exera III Duodenovideoscope Olympus TJF-Q190V
FDA 510(k) clearance K220587 · decided 2022-05-11
Clearance details
- K-number
- K220587
- Device name
- Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-01
- Decision date
- 2022-05-11
- Days to decision
- 71 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 |
|---|---|---|
| Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duoden recall (Z-2676-2026) | Olympus Corporation of the Americas | 2026-07-07 |
| Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V recall (Z-1911-2025) | Olympus Corporation of the Americas | 2025-06-05 |
| Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- de recall (Z-1071-2024) | Olympus Corporation of the Americas | 2024-02-09 |
| EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V recall (Z-2467-2023) | Olympus Corporation of the Americas | 2023-08-28 |