FDA 510(k)

艾拉科尔系统，配备微孔技术

K号: K252752 · 2025-10-30

决定日期2025-10-30

产品代码QAI

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决定实质等同

器械摘要

ellacor System with Micro-Coring Technology is the device name listed in this FDA 510(k) record. The listed applicant is Cytrellis Biosystems, Inc.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K252752. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Cytrellis Biosystems, Inc.. The 510(k) number is K252752.

When did ellacor System with Micro-Coring Technology receive FDA 510(k) clearance?

ellacor System with Micro-Coring Technology received FDA 510(k) clearance on 2025-10-30, under 510(k) number K252752.

Who is the listed applicant for ellacor System with Micro-Coring Technology?

The FDA 510(k) record lists Cytrellis Biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

列明Cytrellis Biosystems, Inc.为申报人的其他记录

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K202517Cytrellis表皮微钻孔系统

官方来源

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