510(k) K183525
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2019
- Date Received
- December 19, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasound Bronchoscope
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- EN
- Submission Type
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).