Fluido Compact Blood and Fluid Warming System
Summary
The Surgical Company International B.V. received 510(k) clearance for Fluido Compact Blood and Fluid Warming System, a LGZ device. Cleared on 2023-06-05.
Details
Source
510(k) Clearance
External ID
K211618
Action Date
2023-06-05
Status
Traditional
Category
device
Product Code
LGZ
Product Description
Fluido Compact Blood and Fluid Warming System. Product code: LGZ.
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. The Surgical Company International B.V. has received 2 total clearances in our database.
The Surgical Company International B.V. has 2 FDA actions in our database, including 2 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 The Surgical Company International B.V. have FDA actions?
The Surgical Company International B.V. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K211618" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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