ellacor System with Micro-Coring Technology
K-Number: K252752 · 2025-10-30
ApplicantCytrellis Biosystems, Inc.
Decision Date2025-10-30
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ellacor System with Micro-Coring Technology is a medical device manufactured by Cytrellis Biosystems, Inc.. It received FDA 510(k) clearance on 2025-10-30 under approval number K252752. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ellacor System with Micro-Coring Technology?
ellacor System with Micro-Coring Technology is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by Cytrellis Biosystems, Inc.. The 510(k) number is K252752.
When was ellacor System with Micro-Coring Technology approved by the FDA?
ellacor System with Micro-Coring Technology received FDA 510(k) clearance on 2025-10-30, under approval number K252752.
What company makes ellacor System with Micro-Coring Technology?
ellacor System with Micro-Coring Technology is manufactured by Cytrellis Biosystems, Inc..
What is the FDA product code for ellacor System with Micro-Coring Technology?
The FDA product code for ellacor System with Micro-Coring Technology is QAI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.