EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
FDA 510(k) clearance K201758 · decided 2021-01-21
Clearance details
- K-number
- K201758
- Device name
- EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-29
- Decision date
- 2021-01-21
- Days to decision
- 206 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 |
|---|---|---|
| Model No. BF-P190, EVIS EXERA III Bronchovideoscope recall (Z-0686-2024) | Shirakawa Olympus Co., Ltd. | 2024-01-09 |
| Model No. BF-XP190, EVIS EXERA III Bronchovideoscope recall (Z-0687-2024) | Shirakawa Olympus Co., Ltd. | 2024-01-09 |
| Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial recall (Z-0327-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 recall (Z-0194-2024) | Olympus Corporation of the Americas | 2023-11-09 |
| Olympus Bronchovideoscope, Models BF-P190 & BF-XP190. recall (Z-2500-2023) | Olympus Corporation of the Americas | 2023-08-31 |