EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
FDA 510(k) clearance K172726 · decided 2018-04-30
Clearance details
- K-number
- K172726
- Device name
- EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-11
- Decision date
- 2018-04-30
- Days to decision
- 231 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 |
|---|---|---|
| Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial recall (Z-0327-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Olympus Bronchovideoscope, Models BF-MP190F. recall (Z-2497-2023) | Olympus Corporation of the Americas | 2023-08-31 |