Balloon BS-3
Summary
Fujifilm Corporation received 510(k) clearance for Balloon BS-3, a FDA device. Cleared on 2021-10-29.
Details
Source
510(k) Clearance
External ID
K213195
Action Date
2021-10-29
Status
Special
Category
device
Product Code
FDA
Product Description
Balloon BS-3. Product code: FDA.
Company
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. Fujifilm Corporation has received 27 total clearances in our database.
Fujifilm Corporation has 27 FDA actions in our database, including 27 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 Fujifilm Corporation have FDA actions?
Fujifilm Corporation has 27 FDA actions in our database, including 0 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213195" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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