Summary
Fci (France Chirurgie Instrumentation) Sas received 510(k) clearance for EZYPOR, a HPZ device. Cleared on 2022-06-24.
Details
Source
510(k) Clearance
External ID
K212741
Action Date
2022-06-24
Status
Traditional
Category
device
Product Code
HPZ
Product Description
EZYPOR. Product code: HPZ.
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.
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 Fci (France Chirurgie Instrumentation) Sas have FDA actions?
This is the only FDA action we have on record for Fci (France Chirurgie Instrumentation) Sas in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212741" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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