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FDA 510(k)

i-Cut

K-Number: K243821 · 2025-04-25

ApplicantA.M.I. Agency For Medical Innovations GmbH
Decision Date2025-04-25
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the i-Cut?

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

When was i-Cut approved by the FDA?

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

What company makes i-Cut?

i-Cut is manufactured by A.M.I. Agency For Medical Innovations GmbH.

What is the FDA product code for i-Cut?

The FDA product code for i-Cut is HET.

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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.

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