Ultrasound Bronchoscope
FDA product code PSV · Class II (moderate risk) · 21 CFR 892.1550 · Radiology
An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
4510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FPSV · Traditional | Olympus Medical Systems Corp. | 09/06/2019SE |
| K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka Ssd-Alpha 5/10…PSV · Traditional | Olympus Medical Systems Corporation | 07/05/2007SE |
| K021204 | Olympus BF Type UM40PSV · Traditional | Olympus Optical Co., Ltd. | 05/01/2002SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0328-2024 Class II | Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided…Channel air drying process was not validated, and that a small percentage of scopes returned to customers… | Aizu Olympus Co., Ltd. | 09/25/2023Open, Classified |
| Z-2494-2023 Class II | Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too… | Olympus Corporation of the Americas | 07/27/2023Open, Classified |