ellacor System with Micro-Coring Technology
Summary
Cytrellis Biosystems, Inc. received 510(k) clearance for ellacor System with Micro-Coring Technology, a QAI device. Cleared on 2025-10-30.
Details
Source
510(k) Clearance
External ID
K252752
Action Date
2025-10-30
Status
Traditional
Category
device
Product Code
QAI
Product Description
ellacor System with Micro-Coring Technology. Product code: QAI.
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. Cytrellis Biosystems, Inc. has received 2 total clearances in our database.
Cytrellis Biosystems, Inc. has 4 FDA actions in our database, including 2 recalls and 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 Cytrellis Biosystems, Inc. have FDA actions?
Cytrellis Biosystems, Inc. has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252752" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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