510(k) clearance
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- 510(k) number
- K260401
- Applicant
- Olympus Medical Systems Corporation
- Decision date
- Aug 27, 2026
- Date received
- Feb 6, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PSV
- Device type
- Ultrasound Bronchoscope
- Device class
- Class II
- Regulation
- 21 CFR 892.1550
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Hachioji-Shi, JP