FDA 510(k)

i-Cut

K号: K243821 · 2025-04-25

申请人A.M.I. Agency For Medical Innovations GmbH

决定日期2025-04-25

产品代码HET

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决定实质等同

器械摘要

i-Cut is the device name listed in this FDA 510(k) record. The listed applicant is A.M.I. Agency For Medical Innovations GmbH. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243821. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the i-Cut?

i-Cut is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is A.M.I. Agency For Medical Innovations GmbH. The 510(k) number is K243821.

When did i-Cut receive FDA 510(k) clearance?

i-Cut received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243821.

Who is the listed applicant for i-Cut?

The FDA 510(k) record lists A.M.I. Agency For Medical Innovations GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-Cut?

The FDA product code for i-Cut is HET.

相关器械（代码：HET）

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