510(k) K183525
K183525 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F". The FDA issued a decision of Substantially Equivalent on Sep 6, 2019. The device falls under product code PSV (Ultrasound Bronchoscope), a Class II device regulated under 21 CFR 892.1550. Olympus Medical Systems Corp. has 103 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 6, 2019
- Date Received
- Dec 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
- 510(k)
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).