EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
Summary
Olympus Medical Systems Corporation received 510(k) clearance for EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F), a PSV device. Cleared on 2026-08-27.
Details
Source
510(k) Clearance
External ID
K260401
Action Date
2026-08-27
Status
Traditional
Category
device
Product Code
PSV
Product Description
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F). Product code: PSV.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 445 device clearances issued this month. Olympus Medical Systems Corporation has received 33 total clearances in our database.
Olympus Medical Systems Corporation has 33 FDA actions in our database, including 33 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Olympus Medical Systems Corporation have FDA actions?
Olympus Medical Systems Corporation has 33 FDA actions in our database, including 0 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260401" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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