BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
FDA 510(k) clearance K963033 · decided 1996-09-09
Clearance details
- K-number
- K963033
- Device name
- BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-05
- Decision date
- 1996-09-09
- Days to decision
- 35 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
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial recall (Z-0327-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP. recall (Z-0337-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Olympus Bronchovideoscope, Models BF-3C160. recall (Z-2503-2023) | Olympus Corporation of the Americas | 2023-08-31 |