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FDA 510(k)

CHIKAI Nexus 014

K-Number: K243383 · 2025-04-21

ApplicantAsahi Intecc Co., Ltd.
Decision Date2025-04-21
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHIKAI Nexus 014 is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-04-21 under 510(k) number K243383. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHIKAI Nexus 014?

CHIKAI Nexus 014 is a medical device that received FDA 510(k) clearance on 2025-04-21. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K243383.

When did CHIKAI Nexus 014 receive FDA 510(k) clearance?

CHIKAI Nexus 014 received FDA 510(k) clearance on 2025-04-21, under 510(k) number K243383.

Who is the listed applicant for CHIKAI Nexus 014?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHIKAI Nexus 014?

The FDA product code for CHIKAI Nexus 014 is MOF.

Other records listing Asahi Intecc Co., Ltd. as applicant

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Related Devices (Code: MOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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