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FDA 510(k)

Medyssey Navigation System

K-Number: K242806 · 2025-04-16

ApplicantMedyssey Co, Ltd.
Decision Date2025-04-16
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Medyssey Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey Co, Ltd.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K242806. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medyssey Navigation System?

Medyssey Navigation System is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Medyssey Co, Ltd.. The 510(k) number is K242806.

When did Medyssey Navigation System receive FDA 510(k) clearance?

Medyssey Navigation System received FDA 510(k) clearance on 2025-04-16, under 510(k) number K242806.

Who is the listed applicant for Medyssey Navigation System?

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

What is the FDA product code for Medyssey Navigation System?

The FDA product code for Medyssey Navigation System is OLO.

Other records listing Medyssey Co, Ltd. as applicant

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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