nextaro® v, 20/20
Summary
Sfm Medical Devices GmbH received 510(k) clearance for nextaro® v, 20/20, a LHI device. Cleared on 2024-04-16.
Details
Source
510(k) Clearance
External ID
K240748
Action Date
2024-04-16
Status
Special
Category
device
Product Code
LHI
Product Description
nextaro® v, 20/20. Product code: LHI.
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. Sfm Medical Devices GmbH has received 2 total clearances in our database.
Sfm Medical Devices GmbH 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 Sfm Medical Devices GmbH have FDA actions?
Sfm Medical Devices GmbH 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 "K240748" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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