EVIS EXERA III Bronchovideoscope Olympus BF-XT190
FDA 510(k) clearance K183419 · decided 2019-09-05
Clearance details
- K-number
- K183419
- Device name
- EVIS EXERA III Bronchovideoscope Olympus BF-XT190
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-10
- Decision date
- 2019-09-05
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190 recall (Z-0193-2024) | Olympus Corporation of the Americas | 2023-11-09 |
| Olympus Bronchovideoscope, Models BF-XT190. recall (Z-2498-2023) | Olympus Corporation of the Americas | 2023-08-31 |
| Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190 recall (Z-2017-2023) | Olympus Corporation of the Americas | 2023-07-17 |