K260401
- 510(k) number
- K260401
- Device name
- EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- PSV — Ultrasound Bronchoscope
- Decision date
- 2026-08-27
- Date received
- 2026-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260401.pdf
Official FDA record: K260401
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.