PSV — Ultrasound Bronchoscope Class II
Classification Details
- Product Code
- PSV
- Device Class
- Class II
- Regulation Number
- 892.1550
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Radiology
- Implant
- No
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K183525 | olympus medical systems | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | September 6, 2019 |
| K070983 | olympus medical systems corporation | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALP | July 5, 2007 |
| K021204 | olympus optical co | OLYMPUS BF TYPE UM40 | May 1, 2002 |