Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
Summary
Olympus Medical Systems Corp. received 510(k) clearance for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H), a FCG device. Cleared on 2025-10-24.
Details
Source
510(k) Clearance
External ID
K252646
Action Date
2025-10-24
Status
Traditional
Category
device
Product Code
FCG
Product Description
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H). Product code: FCG.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Olympus Medical Systems Corp. has received 22 total clearances in our database.
Olympus Medical Systems Corp. has 22 FDA actions in our database, including 22 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 Corp. have FDA actions?
Olympus Medical Systems Corp. has 22 FDA actions in our database, including 0 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252646" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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