EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)— 510(k) K260401
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K260401 for EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F), Substantially Equivalent on 2026-08-27. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code PSV
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
Recent devices under product code PSV
view allMore clearances from Olympus Medical Systems Corporation
view allAdverse events under product code PSV
product code PSV- Death
- 6
- Injury
- 305
- Malfunction
- 3,705
- Total
- 4,016
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.